SonoVision Ultrasound Imaging System

K192388

Tissue Differentiation Intelligence, LLC · cleared 2020-03-12 · product code IYN · Radiology

Premarket evidence — what FDA accepted

Device typehardware
source quote (p.4)
“The SonoVision™ Ultrasound Imaging System with Beluga1™ transducer probe is a general purpose, Track 1, ultrasound system intended for use by a qualified physician for the visualization and evaluation of nerves, vascular and other anatomical structures. The Beluga1™ is an ultrasound imaging probe that has been ergonomically designed for use in intraoperative procedures. The system is comprised of the SonoVision™ console & monitor, 10 MHz transducer imaging probe (Beluga1™), and control software.”
AlgorithmFDA source did not state this
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedNo

Validation studies (2)

Bench

sample size not stated

standards: IEC 60601-1-2: 4th edition (19-8) Medical Electrical Equipment - Part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic disturbances - requirements and tests, IEC 60601-1-1: 2005/(R)2012 And A1:2012 (19-4) Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: general requirements [including: corrigendum 1 (2011)], IEC 60601-2-37 ED 2.1 2015 medical electrical equipment – Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment, IEC 62359 Ed 2.1 2017-09 Ultrasonics - field characterization - test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields [Including: technical corrigendum 1 (2011)], NEMA UD 2 revision 3 2009 Acoustic output measurement standard for diagnostic ultrasound equipment, ISO 10993-1 5th edition 2018-08 for limited exposure, external communicating device. ISO 10993-1 Annex A Table A.1 – Evaluation tests for consideration indicate biological effects cytotoxicity, sensitization, irritation or intracutaneous reactivity be evaluated for the medical device category of the transducer., ISO 14937:2009 Sterilization of healthcare products-General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices.

Retrospective clinical

sample size not stated

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/K192388