Ventripoint Medical System Plus (VMS+)

K173810

Ventripoint Diagnostics, Ltd. · cleared 2018-05-14 · product code IYN · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“The Ventripoint Medical System Plus (VMS+) is an adjunct system to existing ultrasound imaging systems with accessories and proprietary software.”
AlgorithmKnowledge Based Reconstruction database, KBR heart catalogs containing a variety of heart models
source quote (p.4)
“LV, RA, LA evaluation is accomplished by the addition of KBR heart catalogs containing a variety of heart models for each chamber.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedNo

Validation studies (1)

Bench

sample size not stated

endpoints: reconstruction accuracy

standards: IEC 60601-1, IEC 60601-1-2, ISO 14971:2007

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
6
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K241222 (decision 2025-02-26) from Ventripoint Diagnostics Ltd. for a matching device line ("Ventripoint Medical System Plus (VMS+) 4.0") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K241222

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K191493 (decision 2019-10-16) from Ventripoint Diagnostics, Ltd. for a matching device line ("Ventripoint Medical System Plus (VMS+) 3.0") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K191493

  • recall_reason_pattern

    Software/algorithm-related recall in product code IYN (Philips Ultrasound, LLC, initiated 2025-10-31): "Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining." Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:97843

  • 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 is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:97726

  • recall_reason_pattern

    Software/algorithm-related recall in product code IYN (GE Medical Systems China Co., Ltd. Dev. Zone National Hi-Tech; No., initiated 2025-05-16): "GE HealthCare has become aware that the Estimated Fetal Weight (EFW) measurement data feature on the Versana Premier R3 and LOGIQ F R3 series ultrasound systems can display previou" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:96992

  • recall_reason_pattern

    Software/algorithm-related recall in product code IYN (Siemens Medical Solutions USA, Inc., initiated 2024-08-15): "If ultrasound systems with software, are changed from factory default to : 1) Milliliters per second (ml/sec, mL/sec) or 2) Milliliters per minute (ml/min, mL/min); then systems wi" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:95254

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/K173810