Vivid S60N, Vivid S70N

K200497

GE Medical Systems Ultrasound and Primary Care Diagnostics · cleared 2020-07-16 · product code IYN · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.6)
“Vivid S60N / Vivid S70N 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 semi-automated measurements on a PLAX images using similar process as IMT feature first released on Vivid 7, K051449 and manual workflow on predicate Vivid S60N, Vivid S70N.”
AlgorithmAI (Artificial Intelligence) based Cardiac Auto 2D feature that enables semi-automated measurements on PLAX images; AI based Spectrum Recognition feature that enables automated recognition of common Doppler spectra and automatically starts Auto Doppler measurement or opens the appropriate manual measurement folder.
source quote (p.6)
“AI Auto Measure – 2D: AI (Artificial Intelligence) based Cardiac Auto 2D feature that enables semi-automated measurements on a PLAX images using similar process as IMT feature first released on Vivid 7, K051449 and manual workflow on predicate Vivid S60N, Vivid S70N. 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 (0)

FDA source did not describe a validation study.

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) 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) 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

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K220619 (decision 2022-07-15) from GE Medical Systems Ultrasound and Primary Care Diagnostics, for a matching device line ("Vivid S60N, Vivid S70N") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K220619

  • …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/K200497