Ultrasound System 2300
K223830BK Medical Aps · cleared 2023-04-11 · product code IYN · Radiology
Premarket evidence — what FDA accepted
source quote (p.6)
“The Ultrasound System 2300 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 which are offered in different configurations/models intended for urology, general imaging, surgical and anesthesiology applications. ... Prostate Volume Assist (PVA), AI software feature which provides a workflow improvement to an existing prostate volume measurement and calculation tool.”
source quote (p.20)
“For the testing process, the segmentation part of the algorithm is tested using a standard metric of similarity. The test passed. The final algorithm including both segmentation and caliper placement is verified by visual evaluations by clinical experts validation testing comparing the initial caliper placement by the algorithm compared to manual placement by clinical personnel. The purpose is to compare the prostate volume calculation of PVA with volume measurement performed by clinical personnel.”
Validation studies (1)
Retrospective clinical
n=2,436 images · 2 site(s)
endpoints: Automatic initial caliper placement shall produce a prostate volume estimate that deviates no more than 22% on average from the volume estimate based on manually placed calipers.
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, IEC 60825-1: Ed. 2.0, 2007 - Safety of laser products - part 1: equipment classification, and requirements [including: technical corrigendum 1 (2008), interpretation sheet 1 (2007), interpretation sheet 2 (2007)], 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
Reported performance (2 observations)
source quote (p.21)
“The automatic initial caliper placement was tested with respect to prostate volume calculation accuracy and determined for the 9018 to deviate 11% +/- 6% compared to volume calculation using manual placement.”
source quote (p.21)
“The prostate volume calculation accuracy for the 9048, using the initial placement of the calipers is expected to deviate 7% +/- 15% compared to volume calculation using manual placement.”
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
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K231764 (decision 2023-10-23) from BK Medical Aps for a matching device line ("Ultrasound System 1300") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K231764
- 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).