Vivid E80/ Vivid E90/ Vivid E95

K200743

GE Medical Systems Ultrasound and · cleared 2020-07-23 · product code IYN · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.5)
“Vivid E80 / Vivid E90 / Vivid E95 is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid. The device is intended for use in a hospital environment including echo lab, other hospital settings, operating room, Cath lab and EP lab or in private medical offices. The systems support the following clinical applications: Fetal/Obstetrics, Abdominal (including renal, GYN), Pediatric, Small Organ (breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (adult and pediatric), Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Urology (including prostate), Transesophageal, Transvaginal, Transrectal, Interventional Guidance (including Biopsy, Vascular Access), and Intraoperative (vascular). Modes of operation include: 3D, Real time (RT) 3D Mode (4D), B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD. 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. 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.”
AlgorithmAI (Artificial Intelligence) based Cardiac Auto 2D feature that enables automated measurements and AI based Spectrum Recognition feature that enables automated recognition of common Doppler spectra.
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. 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.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedNo

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

85
recalls in product code, 24mo
554
MAUDE reports in code, 12mo
+85%
vs code's own 3-yr baseline
10
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) 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.

Recalls attributed to this device

  • Recalling firm matches this device's applicant (GE Medical Systems, LLC) — same firm and product code, not necessarily this device · 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 clinical decisions impacting overall care.

    recall event 97726 (openFDA)

  • Recalling firm matches this device's applicant (GE Medical Systems, LLC) — same firm and product code, not necessarily this device · 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 clinical decisions impacting overall care.

    recall event 97726 (openFDA)

  • Recalling firm matches this device's applicant (GE Medical Systems, LLC) — same firm and product code, not necessarily this device · 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 clinical decisions impacting overall care.

    recall event 97726 (openFDA)

  • Recalling firm matches this device's applicant (GE Medical Systems, LLC) — same firm and product code, not necessarily this device · initiated 2025-03-06

    The battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire.

    recall event 96538 (openFDA)

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K200743