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.3)

“Vivid S60N/Vivid S70N 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, Intra-cardiac and Intra-luminal, Interventional Guidance (including Biopsy, Vascular Access), and Intraoperative (vascular). Modes of operation include: 3D/4D Imaging mode, 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 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; AI based Spectrum Recognition feature

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 (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

recalls in product code, 24mo

554

MAUDE reports in code, 12mo

+85%

vs code's own 3-yr baseline

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.

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).