V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic Ultrasound System, XH5 Diagnostic Ultrasound System, V4 Diagnostic Ultrasound System, H4 Diagnostic Ultrasound System, XV4 Diagnostic Ultrasound System, XH4 Diagnostic Ultrasound System

K242511

Samsung Medison Co., Ltd. · cleared 2024-12-10 · product code IYN · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.6)
“V5 Diagnostic Ultrasound System; H5 Diagnostic Ultrasound System; XV5 Diagnostic Ultrasound System; XH5 Diagnostic Ultrasound System; V4 Diagnostic Ultrasound System; H4 Diagnostic Ultrasound System; XV4 Diagnostic Ultrasound System; XH4 Diagnostic Ultrasound System (*Hereinafter referred to_as_V5/H5/XV5/XH5,V4/H4/XV4/XH4 diagnostic ultrasound system) are a general purpose, mobile, software controlled, diagnostic ultrasound system. Their function is to acquire ultrasound data and to display the data as 2D mode, Color Doppler mode, Power Doppler (PD) mode, M mode, Pulsed Wave (PW) Doppler mode, Continuous Wave (CW) Doppler mode, Tissue Doppler Imaging (TDI) mode, Tissue Doppler Wave (TDW) mode, ElastoScan Mode, Combined modes, Multi-Image mode(Dual, Quad), 3D/4D mode. The V5/H5/XV5/XH5, V4/H4/XV4/XH4 diagnostic ultrasound system also give the operator the ability to measure anatomical structures and offer analysis packages that provide information that is used to make a diagnosis by competent health care professionals.”
Algorithmdeep learning based view recognition algorithm
source quote (p.8)
“A deep learning based view recognition algorithm was validated using 280 fetal heart and 540 adult heart images collected at five hospitals.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (6)

Retrospective clinical

n=820 images · 5 site(s)

endpoints: View recognition accuracy; Dice-score; Error rate of area measured value; Error rate of angle measured value; Error rate of circumference measured value; Error rate of diameter measured value

standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 60601-4-2, ISO 10993-1, ISO 14971, NEMA UD 2-2004

Retrospective clinical

n=320 images · 2 site(s)

endpoints: Dice-score; Error rate of circumference measured value; Error rate of distance measured value; Error rate of NT measured value

standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 60601-4-2, ISO 10993-1, ISO 14971, NEMA UD 2-2004

Retrospective clinical

n=680 images · 2 site(s)

endpoints: View recognition accuracy; Dice-score

standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 60601-4-2, ISO 10993-1, ISO 14971, NEMA UD 2-2004

Retrospective clinical

n=600 images · 3 site(s)

endpoints: Dice-score of uterus; Dice-score of endometrium; Errors of uterus feature points; Errors of endometrium feature points; Errors of Measurements performance

standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 60601-4-2, ISO 10993-1, ISO 14971, NEMA UD 2-2004

Retrospective clinical

n=3,999 images · 8 site(s)

endpoints: Average accuracy; Average speed (fps)

standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 60601-4-2, ISO 10993-1, ISO 14971, NEMA UD 2-2004

Retrospective clinical

n=1,675 images · 10 site(s)

endpoints: Average accuracy; Average speed (fps)

standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 60601-4-2, ISO 10993-1, ISO 14971, NEMA UD 2-2004

Reported performance (12 observations)

accuracyas written: “HeartAssist Fetus recognition accuracy”93.21
source quote (p.8)
“(Fetus) The average recognition accuracy is 93.21% (threshold 89%)”
accuracyas written: “HeartAssist Adult recognition accuracy”98.31
source quote (p.8)
“(Adult) The average recognition accuracy is 98.31% (threshold 84%)”
diceas written: “HeartAssist Fetus dice-score”0.88
source quote (p.8)
“(Fetus) The average dice-score is 0.88 (threshold 0.8)”
diceas written: “HeartAssist Adult dice-score”0.93
source quote (p.8)
“(Adult) The average dice-score is 0.93 (threshold 0.9)”
diceas written: “BiometryAssist average dice-score”0.919
source quote (p.10)
“The average dice-score is 0.919 (threshold 0.8)”
accuracyas written: “ViewAssist average recognition accuracy”94.26
source quote (p.12)
“The average recognition accuracy is 94.26% (threshold 89%)”
diceas written: “ViewAssist average dice-score”0.885
source quote (p.12)
“The average dice-score is 0.885 (threshold 0.8)”
diceas written: “UterineAssist average dice-score of uterus”96
source quote (p.13)
“The average dice-score of uterus is 96%”
diceas written: “UterineAssist average dice-score of endometrium”92
source quote (p.13)
“The average dice-score of endometrium is 92%”
f1as written: “UterineAssist errors of Measurements performance”stated without valueCI 2.0 mm or less
source quote (p.13)
“The errors of Measurements performance are 2.0 mm or less”
accuracyas written: “NerveTrack Detection average accuracy”89.91CI 86.51, 93.35
source quote (p.15)
“The average accuracy from 10 image sequence was 89.91% (95% Confidence Interval: 86.51, 93.35)”
accuracyas written: “NerveTrack Segmentation average accuracy”98.3CI 95.43, 100
source quote (p.16)
“The average accuracy from nine image sequences is 98.30% (95% Confidence Interval: 95.43, 100)”

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). 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).

RIGOR™ Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: radar.healthai.com/precedent/device/K242511