Voluson P6, Voluson P8

K213689

GE Healthcare · cleared 2022-02-17 · product code IYN · Radiology

Premarket evidence — what FDA accepted

Device typehardware
source quote (p.3)
“Voluson P6 / Voluson P8 are a general-purpose diagnostic ultrasound system intended for use by a qualified and trained healthcare professional that are legally authorized or licensed by law in the country, state or other local municipality in which he or she practices for ultrasound imaging, measurement, display and analysis of the human body and fluid.”
AlgorithmFDA source did not state this
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
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, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, ISO 14971, NEMA PS 3.1 - 3.20, IEC 62359

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
4
drift signals on this device
  • 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/K213689