The LOGIQ Vita / S20 Series are intended for use by a qualified physician for ultrasound evaluation of Fetal / Obstetrics; Abdominal (including Renal, Gynecology/Pelvic); Pediatric; Small Organ (Breast, Testes, Thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (Adult and Pediatric); Peripheral Vascular; Musculo- skeletal Conventional and Superficial; Urology (including Prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (Abdominal and Vascular).

Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, Shear Wave Elastography, Attenuation Imaging and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/PWD.

The LOGIQ Vita / S20 Series are intended to be used in a hospital or medical clinic.

Device Description

The LOGIQ Vita / S20 Series are full featured, Track 3, general purpose diagnostic ultrasound systems which consists of a mobile console approximately 530 mm wide (Caster), 835 mm deep (front and back handle) and 1314 mm high that provides digital acquisition, processing and display capability. The user interface includes a digital keyboard (physical keyboard as an option), specialized controls, 14-inch high-resolution color touch screen and 23.8-inch Wide screen High-Resolution HDU monitor and 23.8-inch Wide screen High-Resolution LCD monitor.

AI/ML Overview

The provided FDA 510(k) clearance letter and summary do not contain detailed information about specific acceptance criteria, reported device performance metrics, or a study specifically designed to prove that the device meets those criteria.

The submission is for a new diagnostic ultrasound system (LOGIQ Vita / S20 Series) that leverages the design and clinical data of a predicate device (LOGIQ Fortis K253366). The core argument for substantial equivalence is that the new device has "no changes to the features, accessories, or components that require new clinical studies to support substantial equivalence."

This means that the provided document does not describe a new study that proves the device meets acceptance criteria in the way you've requested. Instead, it asserts that because the new device is substantially equivalent to a previously cleared device, the existing evidence for the predicate device's safety and effectiveness applies.

However, based on the information provided, we can infer some details:

1. Table of acceptance criteria and reported device performance:

The document explicitly states: "The subject of this premarket submission, the LOGIQ Vita / S20 Series, leverages the same clinical data as the predicate and no changes to the features, accessories, or components that require new clinical studies to support substantial equivalence."

This implies that the acceptance criteria and reported device performance are identical to those established for the predicate device, LOGIQ Fortis (K253366). Since the details of that predicate device's performance study are not included in this document, we cannot populate this table with specific quantitative metrics.

Acceptance Criteria (Implied from Predicate)	Reported Device Performance (Implied from Predicate)
Safety and effectiveness for listed Indications for Use	Device performs safely and effectively for all listed Indications for Use, consistent with the predicate device.
Compliance with acoustic power levels	Acoustic power levels are below applicable FDA limits.
Biocompatibility of patient contact materials	Transducer and other patient contact materials are biocompatible.
Compliance with electrical, thermal, electromagnetic safety standards	Device complies with ANSI AAMI ES60601-1, IEC 60601-2-37, IEC 60601-1-2, IEC 62359.
Application of risk management processes	Risk analysis and management processes were applied (ISO 14971).
Performance of software features (e.g., UGAP, UGFF, Auto Preset Assistant)	Software features perform identically to the predicate device (except for unsupported features).
Capability for measurements, digital image capture, review, and reporting	Capabilities are the same as the predicate device.

Regarding the study proving the device meets acceptance criteria:

This means there was no new, independent clinical study conducted for the LOGIQ Vita / S20 Series to demonstrate it meets acceptance criteria beyond what was established for the predicate device (LOGIQ Fortis K253366). The substantial equivalence argument relies on the fact that the changes are minor and do not impact the core safety and effectiveness established by the predicate.

Given this, the subsequent questions, which would typically describe such a study, cannot be answered directly from the provided text for the LOGIQ Vita / S20 Series. If such information exists, it would be found in the 510(k) submission for the LOGIQ Fortis (K253366) predicate device.

Based on the provided document, here's what we can state:

2. Sample size used for the test set and the data provenance: Not applicable for a new study. The device "leverages the same clinical data as the predicate," meaning no new test set was used for this 510(k).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for a new study.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for a new study.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. The document mentions "AI algorithms" in the context of UGAP/UGFF features being identical to the predicate, but it does not describe an MRMC comparative effectiveness study to measure human reader improvement.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The document states that the liver assessment features (UGAP/UGFF) utilize AI algorithms, and these are identical to the predicate device. However, it does not describe a standalone performance study specifically for the AI components in this submission. The assertion is that these features have not changed since the predicate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for a new study.
8. The sample size for the training set: Not applicable for a new study.
9. How the ground truth for the training set was established: Not applicable for a new study.

In conclusion, the clearance for the LOGIQ Vita / S20 Series is based on its substantial equivalence to the predicate LOGIQ Fortis (K253366), rather than a new, dedicated study demonstrating its performance against new acceptance criteria. The performance and safety data are derived from the predicate device.

Summary

FDA 510(k) Clearance Letter - K260673

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.04

March 24, 2026

GE Medical Systems Ultrasound and Primary Care Diagnostics
Lee Bush
Regulatory Affairs Director
3200 N Grandview Blvd.
Waukesha, Wisconsin 53188

Re: K260673

Trade/Device Name: LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 Power

Regulation Number: 21 CFR 892.1550
Regulation Name: Ultrasonic pulsed doppler imaging system
Regulatory Class: Class II
Product Code: IYN, IYO, ITX, QIH
Dated: March 2, 2026
Received: March 2, 2026

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.

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K260673 - Lee Bush Page 2

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).

Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).

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 Management System Regulation (QMSR) (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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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-

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K260673 - Lee Bush Page 3

assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Digitally signed by Michael D. O'hara -S
Date: 2026.03.24 15:28:06 -04'00'

For

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

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FORM FDA 3881 (6/20) Page 1 of 1

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.

510(k) Number (if known): K260673

Device Name: LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 Power

Indications for Use (Describe)

The LOGIQ Vita / S20 Series are intended to be used in a hospital or medical clinic.

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

☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
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PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Page 5

GE HealthCare
510(k) Premarket Notification Submission

510(k) Summary - K260673

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

Date: March 19, 2026

Submitter: GE Medical Systems Ultrasound and Primary care Diagnostics, LLC
3200 N Grandview Blvd
Waukesha, WI 53188 USA

Manufacturer: GE Medical Systems (China) Co., Ltd.
No. 19, Changjiang Road,
Wuxi National High-Tech Development Zone,
214028 Jiangsu P. R. China

Primary Contact Person: Lee Bush
Regulatory Affairs Director
GE HealthCare
T:(262)309-9429

Alternate Contact Person: Qingmeng Chen
Regulatory Affairs Leader
GE HealthCare
T: +86-18180590723

Device Trade Name: LOGIQ Vita, LOGIQ Vita Pro, LOGIQ Vita Express, LOGIQ Vita Plus, LOGIQ Vita Power, LOGIQ S20, LOGIQ S20 Pro, LOGIQ S20 Express, LOGIQ S20 Plus, LOGIQ S20 Power

Common / Usual Name: Diagnostic Ultrasound System

Classification Names: Class II

Product Code: IYN (primary), IYO, ITX, QIH (secondary)
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
Medical Image Management and Processing System, 21 CFR 892.2050, 90-QIH

Primary Predicate Device: K253366 LOGIQ Fortis Diagnostic Ultrasound System

Reference Device(s): K250087 Vscan Air
K253370 LOGIQ Totus Diagnostic Ultrasound System

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GE HealthCare
510(k) Premarket Notification Submission

Device description:

Intended Use / Indications for Use:

The LOGIQ Vita / S20 Series are intended to be used in a hospital or medical clinic.

Technology:

The LOGIQ Vita / S20 Series employ the same fundamental scientific technology as its predicate device(s).

Determination of Substantial Equivalence:

The proposed LOGIQ Vita / S20 Series are substantially equivalent to the predicate LOGIQ Fortis (K253366) with regards to intended use, imaging capabilities, technological characteristics, imaging modes, hardware, and safety effectiveness.

The systems are all intended for diagnostic ultrasound imaging and fluid flow analysis.

The proposed LOGIQ Vita / S20 Series and the predicate LOGIQ Fortis (K253366) have the same clinical indications for use.

The proposed LOGIQ Vita / S20 Series employ the same fundamental scientific technology as its predicate device.

The proposed LOGIQ Vita / S20 Series and the predicate LOGIQ Fortis (K253366) have the same imaging modes.

The proposed LOGIQ Vita / S20 Series are manufactured with materials which have been evaluated and found to be safe for the intended use of the device.

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GE HealthCare
510(k) Premarket Notification Submission

The proposed LOGIQ Vita / S20 Series have acoustic power levels which are below the applicable FDA limits.

The proposed LOGIQ Vita / S20 Series and the predicate LOGIQ Fortis (K253366) have the same capability in terms of performing measurements, capturing digital images, reviewing and reporting studies.

The proposed LOGIQ Vita / S20 Series have been designed in compliance with approved electrical and physical safety standards.

The proposed LOGIQ Vita / S20 Series re-use 26 probes previously cleared on predicate LOGIQ Fortis (K253366) without modifications.

The compatible device Vscan Air CL probe has its own clearance with K250087 and is also cleared on Predicate LOGIQ Fortis K253366).

The software features supported on proposed LOGIQ Vita / S20 Series and the predicate LOGIQ Fortis (K253366) are identical except that proposed device do not support the use with Koios Lite, Koios DS Connectivity, and Digital Expert.

The hardware and accessories in proposed LOGIQ Vita / S20 Series and the predicate LOGIQ Fortis (K253366) are similar. The major difference between the proposed LOGIQ Vita / S20 Series and the predicate LOGIQ Fortis (K253366) is the operation panel, monitors and appearance.

The LOGIQ Vita / S20 Series were developed and designed based on LOGIQ Fortis (K253366) and LOGIQ Totus (K253370) as shown in the figure below. It uses the LOGIQ Forits Trolley console base and the LOGIQ Totus Operator Panel (OPIO). The software of LOGIQ Vita / S20 Series is based on LOGIQ Fortis R5.0.1. The LOGIQ Vita series uses the 23.8inch HDU monitor from predicate LOGIQ Fortis (K253366) as its main display and the LOGIQ S20 series uses the 23.8inch LCD monitor from LOGIQ Totus (K253370) as its main display. The industrial design has been refreshed and the covers have been recolored.

Some accessories are not supported with LOGIQ Vita / S20 relative to the predicate: Digital Expert associated tablets, UPS (Uninterruptible Power Supply) kit, B/W Printer, and color printer.

Page 8

GE HealthCare
510(k) Premarket Notification Submission

Comparison table of technological characteristics with predicate device(s):

Characteristic	Proposed Device LOGIQ Vita / S20 Series	Predicate Device LOGIQ Fortis (K253366)	Comparison
Touch Panel	14-inch touch panel	12.1-inch touch panel	Proposed devices use 14-inch Touch Panel from LOGIQ Totus (K253370).
Monitors	23.8" High Resolution HDU monitor 23.8-inch High Resolution LCD monitor	23.8" High contrast LED LCD monitor (or 23.8-inch High Resolution LED LCD monitor as an option)	The proposed LOGIQ Vita uses 23.8inch HDU monitor from predicate LOGIQ Fortis (K253366) and the proposed LOGIQ S20 uses the 23.8inch LCD monitor from LOGIQ Totus (K253370).
Key Software features	Ultrasound-Guided Attenuation Parameter (UGAP), Ultrasound Guided Fat Fraction (UGFF), Auto Preset Assistant, Auto Abdominal Color Assistant 2.0, Auto Abdominal Measure Assistant (Renal, Aorta, CBD)	Ultrasound-Guided Attenuation Parameter (UGAP), Ultrasound Guided Fat Fraction (UGFF), Auto Preset Assistant, Auto Abdominal Color Assistant 2.0, Auto Abdominal Measure Assistant (Renal, Aorta, CBD), KOIS Lite	Identical* except proposed devices do not support Koios Lite.
Options/Utilities	Biopsy w/guidelines, Scan Assistant, ECG, Footswitch, Histogram,	Biopsy w/guidelines, Scan Assistant, ECG, Footswitch, Histogram,	Identical except proposed devices do not support UPS.

Page 9

GE HealthCare
510(k) Premarket Notification Submission

Characteristic	Proposed Device LOGIQ Vita / S20 Series	Predicate Device LOGIQ Fortis (K253366)	Comparison
	Video out, Service Modem, Respirometer, RFID reader	Video out, Service Modem, Respirometer, RFID reader, UPS
Connectivity and Archive	DVR, CD/RW & DVD; IP/DICOM, USB; DICOM Compression, Modem, Ethernet network, Multiple and Multiple Frame send, memory stick, Vscan Air CL support, Send Images via Email, ViewPoint on LOGIQ	B/W & Color printing, DVR, CD/RW & DVD; IP/DICOM, USB; DICOM Compression, Modem, Ethernet network, Multiple and Multiple Frame send, memory stick, Koios DS Connectivity, Vscan Air CL support, Send Images via Email, ViewPoint on LOGIQ, Digital Expert Connectivity	Identical except proposed devices do not support Koios DS Connectivity, Digital Expert Connectivity, or integrated printers.

*There were no modifications or retraining of the liver assessment features (UGAP/UGFF) or the features utilizing AI algorithms since the frontend beamforming hardware, backend processing hardware, and compatible probes are the same as on predicate LOGIQ Fortis (K253366)

Summary of Non-Clinical Tests:

The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic and mechanical safety, and has been found to conform with applicable medical device safety standards. The LOGIQ Vita / S20 Series comply with voluntary standards:

ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)]
IEC 60601-2-37 Edition 3.0 2024
Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 62359 Edition 2.1 2017-09 CONSOLIDATED VERSION
Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields

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GE HealthCare
510(k) Premarket Notification Submission

ISO 10993-1 Fifth edition 2018-08
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 14971 Third Edition 2019-12
Medical devices - Application of risk management to medical devices
NEMA PS 3.1 - 3.20 2024e
Digital Imaging and Communications in Medicine (DICOM) Set
AAMI TIR69:2017/(R2020)
Technical Information Report Risk management of radio-frequency wireless coexistence for medical devices and systems

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, the LOGIQ Vita / S20 Series, leverages the same clinical data as the predicate and no changes to the features, accessories, or components that require new clinical studies to support substantial equivalence.

Conclusion:

Based on the equipment design similarities, conformance to recognized performance standards, and performance testing, GE HealthCare considers the proposed LOGIQ Vita / S20 Series to be as safe, effective, and performs in a substantially equivalent manner as the predicate LOGIQ Fortis (K253366).

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.