Vivid E80, Vivid E90, Vivid E95
K181685GE Medical Systems Ultrasound and Primary Care Diagnostics, · cleared 2018-10-25 · product code IYN · Radiology
Premarket evidence — what FDA accepted
source quote (p.25)
“Vivid E80 / Vivid E90 / Vivid E95 systems are Track 3 diagnostic ultrasound systems primarily intended for cardiac imaging and analysis, but which also includes vascular and general radiology applications. The Vivid E80 / Vivid E90 / Vivid E95 incorporates a variety of electronic array transducers operating in linear, curved linear, sector/phased array or matrix array format, including two dedicated CW transducers. Vivid E80 will support 2D imaging, while Vivid E90 and Vivid E95 will support real time 3D imaging in addition to 2D, and incorporate several real-time 3D transducers. Vivid E80 / Vivid E90 / Vivid 95 consists of a mobile console with keyboard control panel; color LCD/TFT touch panel, an OLED or LCD color video display, DVI connector for optional external video display, and optional image storage and printing devices. It provides high performance ultrasound imaging and analysis and has comprehensive networking and DICOM capability.”
source quote (p.27)
“"Automatic View Recognition” is new functionality based on deep neural network embedded into the software of Vivid E95 / Vivid E90.”
source quote (p.27)
“"Whitelisting" is implemented on the subject Vivid E80 / Vivid E90 / Vivid E95. White listing is a cyber security technology available with Windows 10 Embedded, and is implemented as additional protection against running and infecting the ultrasound system with malware.”
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: ANSI / AAMI ES60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 2005/A1:2012, IEC60601-1-2, Medical Electrical Equipment – Part 1-2: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Compatibility Requirements and Tests, 2007., IEC60601-2-37, Medical Electrical Equipment – Part 2-37: Particular Requirements for the Basic Safety and Essential Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment, 2007-08., ISO10993-1, Biological Evaluation of Medical Devices- Part 1: Evaluation and Testing- Third Edition, 2009, IEC62359, Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields, 2017, ISO14971, Application of risk management to medical devices, 2007, NEMA, 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) 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
- 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
- …and 6 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).