RS85 Diagnostic Ultrasound System
K240516Samsung Medison Co., Ltd. · cleared 2024-06-12 · product code IYN · Radiology
Premarket evidence — what FDA accepted
source quote (p.4)
“The RS85 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, Tissue Doppler imaging, Tissue Doppler Wave, 3D imaging mode (real-time 4D imaging mode), Elastoscan+ Mode, MV-Flow Mode or as a combination of these modes.”
source quote (p.6)
“A deep learning based detection algorithm was validated using 3,999 nerve images collected at eight hospitals. A deep learning based segmentation algorithm was validated using 1,753 nerve images collected at ten hospitals. A deep learning based detection algorithm was validated using 50 median nerve images collected at a hospital.”
Validation studies (3)
Retrospective clinical
n=3,999 images · 8 site(s)
endpoints: accuracy; speed (fps); dice coefficient
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: 2020-09(4.1 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, IEC TR 60601-4-2 Edition 1.0 2016-05, Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems, AAMI / ANSI / ISO 10993-1:2018/(R)2013, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process, ISO 14971:2019, Medical devices - Application of risk management to medical devices, NEMA UD 2-2004 (R2009) Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3
Retrospective clinical
n=1,753 images · 10 site(s)
endpoints: accuracy; speed (fps); Dice similarity coefficient; Hausdorff distance
Retrospective clinical
n=50 images · 1 site(s)
endpoints: error rate of FR; error rate of CSA
Reported performance (3 observations)
source quote (p.6)
“The average accuracy from 10 image sequence was 89.6% (95% Confidence Interval: 86.41, 92.79)”
source quote (p.7)
“The average accuracy from nine image sequence is 99.78% (95% Confidence Interval: 99.34, 100)”
source quote (p.7)
“The average Dice similarity coefficient is 90.44% (95% Confidence Interval: 86.19, 94.69)”
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).