Vivid E80/ Vivid E90/ Vivid E95
K200743GE Medical Systems Ultrasound and · cleared 2020-07-23 · product code IYN · Radiology
Premarket evidence — what FDA accepted
source quote (p.4)
“Vivid E80 / Vivid E90 / Vivid E95 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: AI (Artificial Intelligence) based Cardiac Auto 2D feature that enables automated measurements on a PLAX images using similar process as IMT feature first released on Vivid 7, K051449 and manual workflow on predicate Vivid E95, K150087.”
source quote (p.6)
“AI Auto Measure – 2D: AI (Artificial Intelligence) based Cardiac Auto 2D feature that enables automated measurements on a PLAX images using similar process as IMT feature first released on Vivid 7, K051449 and manual workflow on predicate Vivid E95, K150087. This saves time compared to manual measurements, due to elimination of user interactions (clicks) by 79% (4 vs. 19). AI Auto Measure – 2D may also reduce inter-observer variability. AI Auto Measure – Spectrum Recognition: 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. AFI 3.0: based on AFI 2.0 (cleared in Vivid E80/E90/E95, K181685), adds the ability to analyze the left ventricle on both GEHC raw data images and DICOM images from 3rd party ultrasound scanners. Auto EF 3.0: based on Auto EF 2.0 (cleared in K181685), adds the ability to assess LV function on raw data images acquired with GEHC scanners as well as on DICOM images from other vendors systems. AFI RV: based on AFI 2.0 (cleared in K181685) but modified for the right ventricle (RV). It is a parametric tool giving quantitative data for right ventricular longitudinal global strain, free wall strain and segmental strain derived from the apical 4-chamber RV focused view. AFI LA: based on AFI 2.0 (cleared in K181685) but modified for the left atrium. It provides quantitative data for left atrial (LA) global strain. The tool also supports measurements of LA volumes and emptying fraction (EF).”
Validation studies (1)
Bench
sample size not stated
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
- 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) 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) K221147 (decision 2022-07-18) from GE Medical Systems Ultrasound and Primary Care Diagnostics, for a matching device line ("Vivid T8, Vivid T9") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K221147
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K200708 (decision 2020-09-09) from GE Medical Systems Ultrasound and 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:K200708
- …and 4 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).