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
source quote (p.3)
“The Vivid T9/Vivid T8 is a general-purpose ultrasound system, specialized for use in cardiac imaging.”
AlgorithmAI (Artificial Intelligence) based Cardiac Auto 2D feature that enables semi-automated measurements on a PLAX image. 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, Auto EF 3.0, AFI RV, and AFI LA are features based on AFI 2.0 for analyzing left ventricle, assessing LV function, and providing quantitative data for right ventricular longitudinal global strain and left atrial global strain, respectively.
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. AFI 3.0: same feature as cleared on Vivid S70N(K200497), based on AFI 2.0, 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: same feature as cleared on Vivid S70N(K200497), based on Auto EF 2.0, 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: same feature as cleared on Vivid S70N(K200497), based on AFI 2.0, 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: same feature as cleared on Vivid S70N(K200497), based on AFI 2.0, 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).”
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

standards: AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, IEC 62359, ISO 14971, NEMA PS 3.1 – 3.20

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
11
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.

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/K200851