March 28, 2024

GE OEC Medical Systems, Inc.

℅ Shawn Quigley
Regulatory Affairs Manager
384 Wright Brothers Drive
SALT LAKE CITY, UT 84116

Re: K233669
Trade/Device Name: OEC 3D
Regulation Number: 21 CFR 892.1650
Regulation Name: Image-Intensified Fluoroscopic X-Ray System
Regulatory Class: Class II
Product Code: OXO, JAA, OWB
Dated: February 27, 2024
Received: February 28, 2024

Dear Shawn Quigley:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above
and have determined the device is substantially equivalent (for the indications for use stated in the enclosure)
to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment
date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the
provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket
approval application (PMA). You may, therefore, market the device, subject to the general controls
provisions of the Act. Although this letter refers to your product as a device, please be aware that some
cleared products may instead be combination products. The 510(k) Premarket Notification Database
available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination
product submissions. The general controls provisions of the Act include requirements for annual registration,
listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and
adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We
remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be
subject to additional controls. Existing major regulations affecting your device can be found in the Code of
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements
concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA
guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software
Change to an Existing Device" (https://www.fda.gov/media/99785/download).

U.S. Food & Drug Administration

10903 New Hampshire Avenue Doc ID# 04017.06.09
Silver Spring, MD 20993
www.fda.gov
K233669 - Shawn Quigley Page 2

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part
820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming
product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a
change requires premarket review, the QS regulation requires device manufacturers to review and approve
changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and
approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA
has made a determination that your device complies with other requirements of the Act or any Federal
statutes and regulations administered by other Federal agencies. You must comply with all the Act's
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for
devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-
combination-products); good manufacturing practice requirements as set forth in the quality systems (QS)
regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart
A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections
531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR
807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part
803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-
mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including
information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-
devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn
(https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the
Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See
the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE
by email ([email protected]) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Lu Jiang
Lu Jiang, Ph.D.
Assistant Director
Diagnostic X-Ray Systems Team
DHT8B: Division of Radiological Imaging
Devices and Electronic Products
OHT8: Office of Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
 DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120
Food and Drug Administration Expiration Date: 07/31/2026
Indications for Use See PRA Statement below.

Submission Number (ifknown)

K233669
I
Device Name
IOEC 3D

Indications for Use (Describe)

The OEC 3D mobile fluoroscopy system is designed to provide fluoroscopic and digital spot images
of adult and pediatric populations during diagnostic, interventional, and surgical procedures.
Examples of a clinical application may include: orthopedic, gastrointestinal,endoscopic, urologic,
neurologic, vascular, cardiac, critical care, and emergency procedures.

Type of Use (Select one or both, as applicable)

ZPrescription Use (Part 21 CFR 801 Subpart D) ]Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
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information unless it displays a currently valid OMB number."
GE Healthcare
510(k) Premarket Notification Submission – OEC 3D
K233669

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) Summary of Safety and Effectiveness information is submitted in accordance with the
requirement of 21 CFR Part 807.87(h).
In accordance with 21 CFR 807.92 the following summary of information is provided:

Date: March 27, 2024

Submitter: GE OEC Medical Systems, Inc (GE Healthcare)

384 Wright Brothers Drive
Salt Lake City, Utah 84116

Primary Contact: Shawn Quigley

Regulatory Affairs Manager
Tel: 385-475-8853
e-mail: [email protected]

Secondary Contacts: Michelle Huettner

Director, Regulatory Affairs - IGT and Oncology
GE HealthCare
Tel: 901-558-8035
e-mail: [email protected]

PRODUCT IDENTIFICATION

Device Trade Name: OEC 3D

Regulation Name: Image-intensified Fluoroscopic x-ray system

Classification Panel: Radiology
Regulation: 21CFR 892.1650
Classification: Class II
Product Code: OXO
Subsequent Product Codes JAA, OWB
Manufacturer: GE OEC Medical Systems, Inc (GE HealthCare)
384 Wright Brothers Drive.
Salt Lake City, Utah 84116
Manufacturing Location: GE OEC Medical Systems, Inc (GE HealthCare)
384 Wright Brothers Drive.
Salt Lake City, Utah 84116

Predicate Device:
Device Name: OEC 3D
510(k) number: K203346
Manufacturer: GE OEC Medical Systems, Inc

Page 1 of 8
GE Healthcare
510(k) Premarket Notification Submission – OEC 3D

Regulation Name: Image-intensified Fluoroscopic x-ray system

Regulation: 21CFR 892.1650
Classification: Class II
Product Code: OXO
Subsequent Product Code: OWB, JAA

Device Description:
The OEC 3D is a mobile fluoroscopic C-Arm imaging system used to assist trained surgeons
and other qualified physicians. The system is used to provide fluoroscopic X-ray images and
volumetric reconstructions during diagnostic, interventional, and surgical procedures. These
images help the physician visualize the patient’s anatomy and interventional tools. This
visualization helps to localize clinical regions of interest and pathology. The images provide
real-time visualization and records of pre-procedure anatomy, in vivo-clinical activity and
post-procedure outcomes.
The system is composed of two major components, a C-Arm and a tethered Workstation.
The C-Arm is a stable mobile platform capable of performing linear motions (vertical,
horizontal) and rotational motions (orbital, lateral) that allow the user to position the X-ray
image chain at various angles and distances with respect to the patient anatomy to be
imaged. The C-Arm is comprised of the high voltage generator, software, X-ray control, and
a “C” shaped image gantry, which supports an X-ray tube and a Flat Panel Detector. Its
functionality is controlled by software on the Workstation and on the OEC Touch, a digital
flat panel controller mounted on the cross-arm.
The workstation is a stable mobile platform with an articulating arm supporting a color
image high resolution LCD display monitor. It also includes image processing
equipment/software, recording devices, data input/output devices and power control systems.
The Workstation is the primary user interface to the system and can be located at a
convenient location in the room independent of where the C-Arm is located.
On the C-Arm, the generator remains unchanged from the predicate device OEC 3D. This is
also true for the 31 cm x 31 cm image receptor, consisting of a Thallium-doped Cesium
Iodide [CsI (Tl)] solid state flat panel X-ray detector with Complementary Metal Oxide
Semiconductor (CMOS) light imager. The X-ray tube housing and insert remains the same
as on the predicate OEC 3D (K203346).
C-Arm functionality is managed by a digital flat tablet control panel mounted on the C-arm
base. Motion is controlled by a joystick.
On the workstation, the main hardware includes a computer with integrated wireless
capability and a dedicated computer for 3D reconstruction located within the storage bay.
The OEC 3D employs the same software architecture and platform design that fully supports
the flat panel detector as the predicate OEC 3D and complies with IEC 60601-1.
The purpose of this Premarket Notification is to demonstrate that the subject device, OEC 3D,
is a modification of and is substantially equivalent to the predicate device OEC 3D (K203346).

Page 2 of 8
GE Healthcare
510(k) Premarket Notification Submission – OEC 3D

Proposed Device Modification:

The device name for the subject device remains the same as the cleared predicate: OEC 3D.
(K203346). The proposed modifications are being made to GE HealthCare’s cleared predicate
OEC 3D system (K203346).
The primary modifications to the cleared OEC 3D device are as follows:

1. 3D Spine Centerline Tool with Manual Labeling of the Vertebrae

2. 3D Screw Evaluation Tool
3. Augmented Fluoroscopy

Indications for Use:

The OEC 3D mobile fluoroscopy system is designed to provide fluoroscopic and digital spot
images of adult and pediatric populations during diagnostic, interventional, and surgical
procedures. Examples of a clinical application may include: orthopedic, gastrointestinal,
endoscopic, urologic, neurologic, vascular, cardiac, critical care and emergency procedures.

The intended use and indications for use are unchanged from the predicate device.

Technology:
The indications for use are identical and technology is similar to the predicate device. X-ray
generation and control used with the subject device OEC 3D is identical to the technology
used with the predicate device OEC 3D. The subject OEC 3D device employs the same
fundamental technology as that of the predicate device. The image chain including the X-ray
tube, high voltage generator, collimator, X-ray filters, and detectors, remains unchanged
from the predicate, OEC 3D.

The system continues to meet all applicable IEC 60601-1 series of standards, NEMA XR-27,
and applicable parts of 21CFR Subchapter J. The new performance claims did not require
clinical data in order to establish safety or efficacy.

The OEC 3D device was built upon the existing modular and extensible software
architecture, following the same design control process and software development lifecycle
process that is compliant to IEC 62304 used in the predicate OEC 3D.

The changes described above do not change the control mechanism, operating principle,
energy type, or the scientific technology of the predicate devices.

Page 3 of 8
GE Healthcare
510(k) Premarket Notification Submission – OEC 3D

Table 1: Subject and Predicate Device Comparison

Subject Device Predicate Device Discussion of

Modified OEC 3D OEC 3D (K203346) Differences

X-Ray  Type: rotating anode  Type: rotating anode Identical

Tube  Focal spot: 0.3 mm &  Focal spot: 0.3 mm &
Assembly
0.6 mm 0.6 mm
 Anode heat capacity:  Anode heat capacity:
300,000 HU 300,000 HU
 Anode cooling rate:  Anode cooling rate:
85,000 HU/min 85,000 HU/min
 Housing cooling rate:  Housing cooling rate:
68,000 HU/min 68,000 HU/min
 Housing heat capacity:  Housing heat capacity:
1,800,000 HU 1,800,000 HU

X-ray  High frequency, DC  High frequency, DC Identical

Generator  15 kW  15 kW
 Peak tube potential: 40-  Peak tube potential:
120 kVp 40-120 kVp
 Fluoroscopy: 0.2-10.0  Fluoroscopy: 0.2-10.0
mA mA
 High level fluoro: 0.2-  High level fluoro: 0.2-
20.0 mA 20.0 mA
 Pulsed fluoro: 4, 8, 15,  Pulsed fluoro: 4, 8, 15,
30 pulses/sec 30 pulses/sec
Collimator  Iris  Iris Identical

 Secondary  Secondary
 Tungsten dual leaf  Tungsten dual leaf
X-ray  Auto mode  Auto mode Identical
Control
 Manual mode  Manual mode
Modes

Page 4 of 8
GE Healthcare
510(k) Premarket Notification Submission – OEC 3D

Subject Device Predicate Device Discussion of

Modified OEC 3D OEC 3D (K203346) Differences
 (Normal fluoro, High  (Normal fluoro, High
level fluoro, level fluoro,
Low dose fluoro) Low dose fluoro)
Standards  ANSI/AAMI ES60601-  ANSI/AAMI Identical
Compliance 1 ES60601-1
 IEC 60601-1-2  IEC 60601-1-2
 IEC 60601-1-3  IEC 60601-1-3
 IEC 60601-2-43  IEC 60601-2-43
 IEC 60601-2-54  IEC 60601-2-54
 IEC 60601-1-6  IEC 60601-1-6
 IEC 60825-1  IEC 60825-1
 IEC 62304  IEC 62304
 NEMA DICOM PS  NEMA DICOM PS
3.1-3.20 3.1-3.20
 NEMA XR-27  NEMA XR-27
Imaging  Continuous  Continuous Identical
Modes fluoroscopy fluoroscopy
o Normal dose o Normal dose
o High level dose o High level dose
o Low dose o Low dose
 Pulsed fluoroscopy  Pulsed fluoroscopy
o Normal dose o Normal dose
o High level dose o High level dose
o Low dose o Low dose
 Digital spot  Digital spot
 Digital cine pulse  Digital cine pulse
o Normal dose o Normal dose
o Low dose o Low dose
 Subtraction  Subtraction
o Normal dose o Normal dose
o Low dose o Low dose
 Roadmap  Roadmap
o Normal dose o Normal dose

Page 5 of 8
GE Healthcare
510(k) Premarket Notification Submission – OEC 3D

Subject Device Predicate Device Discussion of

Modified OEC 3D OEC 3D (K203346) Differences
o Low dose o Low dose
3D Imaging  HD+ (30s, 400 images)  HD+ (30s, 400 images) Identical
Modes
 HD+ Low dose (30s,  HD+ Low dose (30s,
400 images) 400 images)
 HD (30s, 400 images)  HD (30s, 400 images)
 HD Low dose (30s,  HD Low dose (30s,
400 images) 400 images)
 SD (30s, 200 images)  SD (30s, 200 images)
 SD Low dose (30s, 200  SD Low dose (30s, 200
images) images)
3D Imaging  Coronal views  Coronal views Substantially
Features Equivalent
 Sagittal views  Sagittal views
3D Spine Centerline
 Axial views  Axial views
Tool with labeling
 Oblique views (Multi-  Oblique views (Multi- identifies vertebrae
Planar Reformat) Planar Reformat) levels in a 3D volume
with centroids and
 3D volume render view  3D volume render view
facilitates oblique
(VR) (VR)
viewing along the
 Maximum Intensity  Maximum Intensity spine centerline
Projection view Projection view defined by the
centroids. The tool
 Window/Level  Window/Level
gives the user the
(brightness/contrast) (brightness/contrast)
option to label
 Image rotation  Image rotation vertebrae levels
 Image zoom  Image zoom manually.
 Metal artifact reduction  Metal artifact reduction 3D Spine Screw
Evaluation Tool is a
 3D Spine Centerline method to select an
Tool with Labeling oblique view for
 3D Spine Screw reviewing screw
Evaluation Tool placement.
 Augmented Augmented
Fluoroscopy fluoroscopy is a

Page 6 of 8
GE Healthcare
510(k) Premarket Notification Submission – OEC 3D

Subject Device Predicate Device Discussion of

Modified OEC 3D OEC 3D (K203346) Differences
method to overlay a
3D point of interest
in an imaging
volume on live
fluoroscopy (2D X-
ray).
The new 3D
imaging features do
not raise new
questions for safety
and effectiveness.

Determination of Substantial Equivalence:

GE HealthCare believes the modified OEC 3D is of comparable type and substantially
equivalent to the cleared predicate OEC 3D.

Non-Clinical Performance Testing

The verification and validation testing have been successfully completed as required by
design control procedures under GE HealthCare’s quality system. The system has been tested
and is compliant with the IEC 60601-1, including IEC 60601-1-2, 60601-1-3, 60601-2-43, and
60601-2-54. All applicable 21CFR Subchapter J performance standards are met., 1020.30
Diagnostic X-Ray Systems and their major components, 1020.32 Fluoroscopic equipment,
1040.10 Laser products.

The OEC 3D system was developed under the GE OEC Medical Systems Quality Management
System, including design controls, risk management and software development life cycle
processes. The following quality assurance measures were applied to the development of the
system:
• Risk Analysis
• Required Reviews
• Design Reviews
• Testing on Unit Level (Module verification)
• Integration testing (System verification)
• Performance testing (Verification)
• Safety testing (Verification)
• Simulated use testing (Validation)

Page 7 of 8
GE Healthcare
510(k) Premarket Notification Submission – OEC 3D

The substantial equivalence was also based on a basic software documentation level.

Additional Non-Clinical Performance Testing

The 3D Centerline Tool with Labeling and the 3D Screw Evaluation Tool performance were evaluated
on cadaveric volume datasets of the spine representing different imaging conditions.

The Augmented Fluoroscopy feature is a method to overlay a 3D point of interest in an imaging

volume on live fluoroscopy (2D X-ray). This method projects a 3D point with some error
compared to its actual position in the associated fluoroscopic image. Performance testing was done
to quantify this error for accuracy using a rigid phantom.

Clinical Testing
The modified OEC 3D device is substantially equivalent to the cleared predicate for OEC 3D.
The indication for use is identical and has equivalent/identical technological characteristics. This
type of notification supports using scientific, established, engineering-based performance testing.
The system has been fully tested using engineering bench testing. Clinical data is not required to
demonstrate substantial equivalence for the modified OEC 3D device compared to the cleared
predicate.

Substantial Equivalence Conclusion:

The OEC 3D device follows the same design control process and software development
lifecycle processes as the predicate OEC 3D (K203346).
The differences discussed in this section do not introduce any adverse effects nor raise new
questions of safety and effectiveness. Based on the successful verification and validation testing,
additional performance bench testing, conformance to standards, and development under GE
OEC Medical System’s Quality Management System, we believe that the modified OEC 3D
device is substantially equivalent to the cleared predicate device OEC 3D (K203346) and
therefore, is safe and effective for its intended use.

Page 8 of 8