SonoVision Ultrasound Imaging System
K192388Tissue Differentiation Intelligence, LLC · cleared 2020-03-12 · product code IYN · Radiology
Premarket evidence — what FDA accepted
source quote (p.3)
“The SonoVision™ Ultrasound Imaging System is a general purpose ultrasound system intended for use by a qualified physician for the visualization and evaluation of nerves, vascular and other anatomical structures. The system provides imaging assistance in spinal procedure applications. The system is comprised of the SonoVision™ console & monitor, 10 MHz transducer imaging probe (Beluga1™), and control software.”
source quote (p.4)
“The system includes image processing software that can be used to define anatomical features in an ultrasound B-mode image.”
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 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
- 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). 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).