Vivid T8, Vivid T9
K221147GE Medical Systems Ultrasound and Primary Care Diagnostics, · cleared 2022-07-18 · product code IYN · Radiology
Premarket evidence — what FDA accepted
source quote (p.5)
“Vivid T9/Vivid T8 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. ... Added Easy Auto EF -based on Auto EF 3.0 (includes AI Auto ROI algorithm)”
source quote (p.7)
“Added Easy Auto EF -based on Auto EF 3.0 (includes AI Auto ROI algorithm)”
Validation studies (1)
Retrospective clinical
n=45 patients
endpoints: accuracy (average dice score)
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, Ed. 2.1, 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, 2019, NEMA PS 3.1 – 3.20, Digital Imaging and Communications in Medicine (DICOM) Set. (Radiology), 2016
Reported performance (1 observation)
source quote (p.8)
“The accuracy of the AI algorithm (average dice score) as tested on datasets from different countries, is 92% or higher; as tested on datasets from different scanning views, is 91% or higher; as tested on dataset from different left ventricle volumes, is 92% or higher.”
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
- 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
- recall_reason_pattern
Software/algorithm-related recall in product code IYN (Philips Ultrasound, LLC, initiated 2025-10-31): "Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining." Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:97843
- …and 2 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).