GE Medical Systems Ultrasound and Primary Care Diagnostic November 3, 2023

c/o Lee Bush

Regulatory Affairs Director, GE HealthCare
LLC 9900 Innovation Dr.
WAUWATOSA WI 53226

Re: K232186
Trade/Device Name: LOGIQ e
Regulation Number: 21 CFR 892.1550
Regulation Name: Ultrasonic Pulsed Doppler Imaging System
Regulatory Class: Class II
Product Code: IYN, IYO, ITX
Dated: October 2, 2023
Received: October 2, 2023

Dear Lee Bush:

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# 04017.06.05
Silver Spring, MD 20993
www.fda.gov
K232186 - Lee Bush 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,

Yanna S. Kang -S
Yanna Kang, Ph.D.
Assistant Director
Mammography and Ultrasound Team
DHT8C: Division of Radiological Imaging
and Radiation Therapy Devices
OHT8: Office of Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure
 GE HealthCare
510(k) Premarket Notification Submission

K232186

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510(k) Premarket Notification Submission

510(k) Summary K232186

In accordance with 21 CFR 807.92 the following summary of information is provided:

Date: 24 July, 2023

Submitter: GE Medical Systems Ultrasound and Primary Care Diagnostics
9900 Innovation Drive
Wauwatosa, WI 53226

Primary Contact Person: Lee Bush

Regulatory Affairs Director
GE HealthCare
T: (262)309-9429

Secondary Contact Person: Yuan Wang

Regulatory Affairs Leader
GE HealthCare

Device Trade Name: LOGIQ e

Common/Usual Name: Diagnostic Ultrasound System
Classification Names: Class II
Product Code(s): Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550, 90- IYN;
Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO;
Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX

Predicate Device: LOGIQ e (K151028), Diagnostic Ultrasound System

Classification Names: Class II
Product Code(s): Ultrasonic Pulsed Doppler Imaging System, 21CFR 892.1550, 90-IYN;
Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO;
Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX

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Reference Device: Vivid iq (K221148), Diagnostic Ultrasound System

Classification Names: Class II
Product Code(s): Ultrasonic Pulsed Doppler Imaging System, 21CFR 892.1550, 90-IYN;
Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO;
Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX

Reference Device: Versana Premier (K210438), Diagnostic Ultrasound System

Classification Names: Class II
Product Code(s): Ultrasonic Pulsed Doppler Imaging System, 21CFR 892.1550, 90-IYN;
Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO;
Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX

Reference Device: Venue Go (K202233), Diagnostic Ultrasound System

Classification Names: Class II
Product Code(s): Ultrasonic Pulsed Doppler Imaging System, 21CFR 892.1550, 90-IYN;
Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO;
Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX

Device Description:
The proposed LOGIQ e system is a general-purpose, Track 3, diagnostic ultrasound device,
intended for ultrasound imaging, measurement, display and analysis of the human body and
fluid.

It is an ultrasound imaging & analysis system, consisting of a compact console with LCD, and
control panel with new keyboard.

The system has digital acquisition, processing and display capability and operates from an
integrated battery or AC/DC power adapter. It has one battery pack as standard configuration
and also with an optional battery pack to be provided for additional power for longer scanning
time.

The system also has an optional height-adjustable cart for comfortable standing and sitting
positions. The cart is approx. 510mm length, 510mm width and adjustable height from 830 to
1130mm with optional battery box consisting of a charger box and 4pcs battery Packs to
supply the system power from the cart.

LOGIQ e utilizes a variety of electronic array transducers operating in linear, curved,

sector/phased array, TEE.

The system includes electronics for transmit and receive of ultrasound data, ultrasound signal

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processing, software computing, hardware for image storage, printing, and network access to
the facility through both LAN and wireless (supported by use of a wireless LAN USB-adapter)
connection.

The system supports electronic delivery of software. The system allows the user, in addition to
service personnel, to update the SW by logging into a GEHC website to download SW
available to them and install it on the system. Download from the GEHC website requires an
account.

Intended Use/Indication For Use:

The LOGIQ e is a general purpose diagnostic ultrasound system for use by qualified and trained
HealthCare professionals for ultrasound imaging, measurement, display and analysis of the human
body and fluid.

LOGIQ e is intended to be used in a hospital or medical clinic.

LOGIQ e clinical application include: Ophthalmic, fetal/ob; abdominal (gyn & urology); pediatric;
small organ (breast, testes, thyroid); neonatal and adult cephalic; cardiac (adult & pediatric);
peripheral vascular; musculoskeletal conventional & superficial; transrectal; transvaginal;
transesophageal; intraoperative (abdominal, thoracic and peripheral); thoracic/pleural for motion
and fluid detection and imaging guidance of interventional procedures (e.g. Nerve block; vascular
access). Mode of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M
Doppler, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/PWD,
B/Color/PWD, B/Power/PWD.

Technology:
The LOGIQ e employs the same fundamental scientific technology as its predicate device.

Determination of Substantial Equivalence:

The proposed LOGIQ e system is substantially equivalent to the predicate device LOGIQ e and
reference devices with regards to intended use, imaging capabilities, technological characteristics
and safety and effectiveness.

The following is an overview of the differences between the proposed LOGIQ e and its predicate
device.

Indications for use:

The proposed LOGIQ e and predicate LOGIQ e (K151028) have similar clinical indications
for use. There are no additional clinical applications, however the indications for use
wording has been modified to align with FDA’s new ultrasound guidance issued on 21-Feb-

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2023, identify users similar to reference device Versana Premier (K210438), and provide
information on the environments the system can be used in.

Transducer and modes:

 The proposed LOGIQ e and predicate LOGIQ e (K151028) have identical imaging
modes.
 The proposed LOGIQ e and predicate LOGIQ e (K151028) transducers are similar,
except for:
o Addition of L4-20t-RS, which was previous cleared on Vivid iq (K221148). The
clinical applications and imaging modes of L4-20t-RS are similar on the proposed
LOGIQ e as they are on the reference device Vivid iq (K221148).
o Addition of 12S-RS, which was previous cleared on Vivid iq (K221148). The
clinical applications and imaging modes of 12S-RS are similar on the proposed
LOGIQ e as they are on the reference device Vivid iq (K221148).
 The Thoracic/Pleural is added to the transducer C1-5-RS, based on the clearance of
refence device Vivid iq (K221148).
 Pediatric are added to the transducer L10-22-RS, based on the clearance of reference
device Venue Go (K202233).

Software:
 Added AutoEF – cleared in Versana Premier (K210438)
 Added Scan assistant – cleared in Versana Premier (K210438)
 Added Strain Elastography, cleared in Versana Premier (K210438)
 Added Probe check (Transducer Element Check), cleared in Versana Premier
(K210438)
 Added Imaging Insights, cleared in Vivid iq (K221148)
 Added Tricefy Uplink, cleared in Vivid iq (K221148)

Hardware:
 New Product Industrial Design with 15.6inch LCD and new keyboard
 Additional option for secondary battery pack to support longer scanning time on
batteries.
 Optimize thermal solution with low noise fan.

Accessories:
 Added compatible OEM biopsy guide accessory compatibility for the L4-20t-RS
transducer

Summary of Non-Clinical Tests:

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LOGIQ e is evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness
as well as thermal, electrical, electromagnetic, and mechanical safety, and have been found to
comply with applicable medical device safety standards. The LOGIQ e complies with voluntary
standards:
 AAMI/ANSI ES60601-1, Medical Electrical Equipment – Part 1: General Requirements for
Safety and Essential Performance, 2005/ A2:2012
 ANSI AAMI IEC 60601-1-2:2014 [Including AMD 1:2021], Medical electrical equipment -
Part 1-2: General requirements for basic safety and essential performance - Collateral
Standard: Electromagnetic disturbances - Requirements and tests [Including Amendment 1
(2021)]
 IEC 60601-2-37 Edition 2.1 2015 Medical electrical equipment - Part 2-37: Particular
requirements for the basic safety and essential performance of ultrasonic medical diagnostic
and monitoring equipment
 ISO 10993-1 Fifth edition 2018-08 Biological evaluation of medical devices - Part 1:
Evaluation and testing within a risk management process
 IEC 62359 Edition 2.1 2017-09 Ultrasonics - Field characterization - Test methods for the
determination of thermal and mechanical indices related to medical diagnostic ultrasonic
fields
 ISO 14971, Application of risk management to medical devices, 2019
 NEMA PS 3.1 – 3.20, Digital Imaging and Communications in Medicine (DICOM) Set.
(Radiology), 2021e

The following quality assurance measures are applied to the development of the system:
 Risk Analysis
 Requirements Reviews
 Design Reviews
 Testing on unit level (Module verification)
 Integration testing (System verification)
 Performance testing (Verification & Validation)
 Safety testing (Verification)

Transducer materials and other patient contact materials are biocompatible.

Summary of Clinical Tests:

The subject of this premarket submission, LOGIQ e, did not require clinical studies to support
substantial equivalence.

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Conclusion:
Based on the equipment design similarities, conformance to recognized performance standards,
and performance testing, GE HealthCare considers the proposed LOGIQ e to be as safe, effective,
and performs in a substantially equivalent manner as the predicate device LOGIQ e (K151028) and
reference devices Vivid iq (K221148), Versana Premier (K214038) and Venue Go (K202233).

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