V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System; V5 Diagnostic Ultrasound System; cV5 Diagnostic Ultrasound System; V4 Diagnostic Ultrasound System; cV4 Diagnostic Ultrasound System

K250999

Samsung Medison Co., Ltd. · cleared 2025-07-18 · product code IYN · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.7)
“The proposed_V8/cV8, V7/cV7,V6/cV6 have updated 'BiometryAssist', 'ViewAssist', and 'HeartAssist', the cleared features in the predicate V8/cV8, V7/cV7,V6/cV6 (K243702). The AI models for these features have been updated. The proposed V5/cV5, V4/cV4 have included ‘EzNerveMeasure' previously cleared in the predicate V8/cV8, V7/cV7, V6/cV6 (K243702), as a sub-function of NerveTrack based on AI technology.”
Algorithmdeep learning based view recognition and segmentation algorithms
source quote (p.10)
“A deep learning based view recognition algorithm was validated using 320 fetal biometry images collected at hospitals (South Korea and United States). A deep learning-based segmentation algorithm was validated using 200 median nerve images collected at a hospital.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (8)

Retrospective clinical

n=320 images · 2 site(s)

endpoints: average dice-score is 0.869 (threshold 0.8)

Retrospective clinical

n=320 images · 2 site(s)

endpoints: error rate of circumference measured value is 8% or less.; error rate of distance measured value is 4% or less.; error rate of NT measured value is 1mm or less.

Retrospective clinical

n=680 images · 2 site(s)

endpoints: achieved sensitivity is 93.97% and specificity is 99.62% (thresholds: 75.9%, 88.2%, respectively)

Retrospective clinical

n=680 images · 2 site(s)

endpoints: average dice-score is 0.863 (threshold 0.8)

Retrospective clinical

n=280 images · 2 site(s)

endpoints: achieved sensitivity is 94.29% and specificity is 99.62% (thresholds: 75.9%, 88.2%, respectively)

Retrospective clinical

n=280 images · 2 site(s)

endpoints: average dice-score is 0.865 (threshold 0.8)

Retrospective clinical

n=280 images · 2 site(s)

endpoints: error rate of area measured value is 8% or less.; error rate of angle measured value is 4% or less.; error rate of circumference measured value is 11% or less.; error rate of diameter measured value is 11% or less.

Retrospective clinical

n=200 images · 2 site(s)

endpoints: average error rate of FR was 8.05% (95% Confidence Interval: [7.64, 8.46]); average error rate of CSA was 13.11% (95% Confidence Interval: [11.83, 14.38])

Reported performance (7 observations)

sensitivity0.9397
source quote (p.11)
“The achieved sensitivity is 93.97% and specificity is 99.62% (thresholds: 75.9%, 88.2%, respectively)”
specificity0.9962
source quote (p.11)
“The achieved sensitivity is 93.97% and specificity is 99.62% (thresholds: 75.9%, 88.2%, respectively)”
diceas written: “average dice-score”0.869
source quote (p.10)
“The average dice-score is 0.869 (threshold 0.8)”
diceas written: “average dice-score”0.863
source quote (p.11)
“The average dice-score is 0.863 (threshold 0.8)”
sensitivity0.9429
source quote (p.13)
“The achieved sensitivity is 94.29% and specificity is 99.62% (thresholds: 75.9%, 88.2%, respectively)”
specificity0.9962
source quote (p.13)
“The achieved sensitivity is 94.29% and specificity is 99.62% (thresholds: 75.9%, 88.2%, respectively)”
diceas written: “average dice-score”0.865
source quote (p.13)
“The average dice-score is 0.865 (threshold 0.8)”

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/K250999