Vivid T8, Vivid T9

K200851

GE Medical Systems Ultrasound and Primary Care Diagnostics · cleared 2020-09-09 · product code IYN · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml

source quote (p.4)

“Vivid T8/Vivid T9 is a Track 3, diagnostic ultrasound system, which is primarily intended for cardiac imaging and analysis but also includes vascular and general radiology applications. It is a full featured diagnostic ultrasound system that provides digital acquisition, processing, analysis and display capability. AI Auto Measure - 2D: same feature as cleared on Vivid S70N(K200497). It is AI (Artificial Intelligence) based Cardiac Auto 2D feature that enables semi-automated measurements on a PLAX image.”

AlgorithmAI (Artificial Intelligence) based Cardiac Auto 2D feature; AI based Spectrum Recognition feature

source quote (p.6)

“AI Auto Measure - 2D: same feature as cleared on Vivid S70N(K200497). It is AI (Artificial Intelligence) based Cardiac Auto 2D feature that enables semi-automated measurements on a PLAX image. AI Auto Measure – Spectrum Recognition: same feature as cleared on Vivid S70N(K200497), It is AI based Spectrum Recognition feature that enables automated recognition of common Doppler spectra and automatically starts the Auto Doppler measurement or opens the appropriate manual measurement folder.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (1)

Bench

sample size not stated

endpoints: acoustic output; biocompatibility; cleaning and disinfection effectiveness; thermal safety; electrical safety; electromagnetic safety; mechanical safety

standards: AAMI/ANSI ES60601-1, Medical Electrical Equipment – Part 1: General Requirements for Safety and Essential Performance, 2005/ A2:2012, IEC 60601-1-2, Medical Electrical Equipment – Part 1-2: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Disturbance – Requirements and Tests, 2014, IEC 60601-2-37, Medical Electrical Equipment – Part 2-37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment, 2015, ISO 10993-1, Biological Evaluation of Medical Devices- Part 1: Evaluation and Testing Within A Risk Management Process, 2009, IEC 62359, Ultrasonics – Field characterization – Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields, 2017, ISO 14971, Application of risk management to medical devices, 2007, NEMA PS 3.1 – 3.20, Digital Imaging and Communications in Medicine (DICOM) Set. (Radiology), 2016

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

recalls in product code, 24mo

554

MAUDE reports in code, 12mo

+85%

vs code's own 3-yr baseline

drift signals on this device

recall_reason_pattern
Software/algorithm-related recall in product code IYN (GE Medical Systems, LLC, initiated 2025-09-18): "The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinica" Recalling firm matches this device's applicant.
first seen 2026-07-08 · recall res_event_number:97726
re_clearance
The FDA AI/ML device list shows a newer 510(k) K251169 (decision 2025-07-10) from GE Medical Systems Ultrasound and Primary Care Diagnostics for a matching device line ("Vivid Pioneer") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K251169
re_clearance
The FDA AI/ML device list shows a newer 510(k) K243628 (decision 2025-02-11) from GE Medical Systems Ultrasound and Primary Care Diagnostics for a matching device line ("Vivid T9/Vivid T8") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K243628
re_clearance
The FDA AI/ML device list shows a newer 510(k) K243620 (decision 2025-02-11) from GE Medical Systems Ultrasound and Primary Care Diagnostics for a matching device line ("Vivid iq") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K243620
re_clearance
The FDA AI/ML device list shows a newer 510(k) K220882 (decision 2022-07-22) from GE Medical Systems Ultrasound and for a matching device line ("Vivid E80, Vivid E90, Vivid E95") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K220882
re_clearance
The FDA AI/ML device list shows a newer 510(k) K221148 (decision 2022-07-18) from GE Medical Systems Ultrasound & Primary Care Diagnostics LLC for a matching device line ("Vivid iq") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K221148
…and 5 more.

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).