HS40 Diagnostic Ultrasound System
K221599Samsung Medison Co., Ltd. · cleared 2022-08-22 · product code IYN · Radiology
Premarket evidence — what FDA accepted
source quote (p.5)
“The HS40 is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as 2D mode, M mode, Color Doppler imaging, Power Doppler imaging (including Directional Power Doppler mode; S-Flow), PW Spectral Doppler mode, CW Spectral Doppler mode, Harmonic imaging(S-Harmonic), Tissue Doppler imaging, Tissue Doppler Wave, Panoramic Imaging, Freehand 3D, 3D imaging mode (real-time 4D imaging mode), Elastoscan Mode or as a combination of these modes. The HS40 also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The proposed HS40 has added the UterineAssist based on AI already cleared in the predicate devce V8(K211945) and expanded the detection nerve type (Elbow : MN, UN, RN / Neck&Shoulder : ISBP, SCBP, AxBP) of NerveTrack based on AI in the previously cleared HS40(K210426).”
source quote (p.5)
“The proposed HS40 has added the UterineAssist based on AI already cleared in the predicate devce V8(K211945) and expanded the detection nerve type (Elbow : MN, UN, RN / Neck&Shoulder : ISBP, SCBP, AxBP) of NerveTrack based on AI in the previously cleared HS40(K210426). A deep learning based segmentation algorithm was validated using 450 sagittal uterus images and 150 transverse uterus images collected at three hospitals.”
Validation studies (3)
Retrospective clinical
n=2,146 images
endpoints: Accuracy (%); Speed (FPS)
Retrospective clinical
n=600 images · 3 site(s)
endpoints: average dice-score of uterus; average dice-score of endometrium; errors of uterus feature points; errors of endometrium feature points; errors of Measurements performance
Bench
sample size not stated
standards: AAMI ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD), IEC60601-1-2: 2014(4th Edition), Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - EMC, IEC 60601-2-37 Edition 2.0 2007, Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment, ISO 10993-1:2009/(R)2013, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, ISO 14971:2007, Medical devices - Application of risk management to medical devices, NEMA UD 2-2004 (R2009) Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3
Reported performance (4 observations)
source quote (p.7)
“Accuracy (%) Average 91.7 Standard Deviation 5.6 95% CI 89.5 to 93.9”
source quote (p.8)
“The average dice-score of uterus is 96%”
source quote (p.8)
“The average dice-score of endometrium is 92%”
source quote (p.8)
“The errors of Measurements performance are 2.0 mm or less”
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).