Ultrasound System 1300

K231764

BK Medical Aps · cleared 2023-10-23 · product code IYN · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.6)
“The Ultrasound System 1300 is a multi-purpose mobile, software-controlled diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms.”
AlgorithmProstate Volume Assist (PVA), AI software feature
source quote (p.13)
“Proposed a new Prostate Volume Assist (PVA), AI software feature that has been recently cleared under K223830 for the Reference Predicate device Ultrasound System 2300. PVA provides a workflow improvement to an existing prostate volume measurement and calculation tool.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedNo

Validation studies (2)

Bench

sample size not stated

standards: ANSI/AAMI/ES 60601-: 2005/ (R) 2012 and A1:2012, C1:2009/ (R) 2012 and A2:2010/ (R) 2012 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance, IEC 60601-1-2: Ed. 4.0, 2014 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility - Requirements and tests, IEC 60601-2-37 - Medical Electrical Equipment - Part 2-37: Ed. 2.1, 2017 Requirements for the Basic Safety and Essential Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment, IEC 62359: Ed. 2.1, 2017 - Ultrasonics - Field Characterization - Test Methods for the Determination of Thermal and Mechanical Indices Related to Medical Diagnostic Ultrasonic Fields, AAMI/ANSI/ISO 10993-1: 2018 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk management Process, AAMI TIR-12:2010 and AAMI TIR-30:2011, IEC 62304: 2006/A1:2016 - Medical Device Software Life-Cycle Processes (Software / Informatics), NEMA PS3.1 – 3.20 Digital Imaging and Communications in Medicine (DICOM), ISO14971: 2019 - Application of risk management to medical devices

Retrospective clinical

n=2,436 images · 2 site(s)

endpoints: segmentation similarity; comparison of automatic caliper placement to manual placement; prostate volume calculation comparison to clinical personnel

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/K231764