V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System

K223387

Samsung Medison Co., Ltd. · cleared 2023-02-13 · product code IYN · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.4)
“The V8 / V7 are a general purpose, mobile, software controlled, diagnostic ultrasound system.”
Algorithmdeep learning based segmentation algorithm, deep learning based view recognition algorithm
source quote (p.8)
“A deep learning based segmentation algorithm was validated using 320 fetal biometry images collected at two 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 (4)

Retrospective clinical

n=18 patients

endpoints: Accuracy (%); Speed (FPS)

Retrospective clinical

n=320 images · 2 site(s)

endpoints: average dice-score; error rate of circumference measured value; error rate of distance measured value; error rate of NT(Nuchal Translucency) measured value

Retrospective clinical

n=680 images · 2 site(s)

endpoints: average recognition accuracy

Retrospective clinical

n=888 images · 5 site(s)

endpoints: view recognition accuracy; segmentation dice-score; size measurement error rate (area); size measurement error rate (angle); size measurement error rate (circumference); size measurement error rate (diameter); Pearson correlation coefficient (PCC)

Reported performance (7 observations)

accuracyas written: “NerveTrack Accuracy (%)”90.3CI 88.6 to 92.0
source quote (p.7)
“Accuracy (%) Average 90.3 95% CI 88.6 to 92.0”
diceas written: “BiometryAssist average dice-score”0.928
source quote (p.8)
“The average dice-score is 0.928 (threshold 0.8)”
accuracyas written: “ViewAssist average recognition accuracy”94.56
source quote (p.9)
“The average recognition accuracy is 94.56% (threshold 89%)”
accuracyas written: “HeartAssist (Fetus) average recognition accuracy”93.21
source quote (p.11)
“(Fetus) The average recognition accuracy is 93.21% (threshold 89%)”
accuracyas written: “HeartAssist (Adult) average recognition accuracy”98.31
source quote (p.11)
“(Adult) The average recognition accuracy is 98.31% (threshold 84%)”
diceas written: “HeartAssist (Fetus) average dice-score”0.88
source quote (p.11)
“(Fetus) The average dice-score is 0.88 (threshold 0.8).”
diceas written: “HeartAssist (Adult) average dice-score”0.93
source quote (p.11)
“(Adult) The average dice-score is 0.93 (threshold 0.9).”

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
14
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K252018 (decision 2026-01-05) from Samsung Medison Co., Ltd. for a matching device line ("HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound System") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K252018

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K250999 (decision 2025-07-18) from Samsung Medison Co., Ltd. for a matching device line ("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") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K250999

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K243702 (decision 2025-02-12) from Samsung Medison Co., Ltd. for a matching device line ("V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K243702

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K242511 (decision 2024-12-10) from Samsung Medison Co., Ltd. for a matching device line ("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") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K242511

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K242444 (decision 2024-11-27) from Samsung Medison Co., Ltd. for a matching device line ("HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K242444

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K241971 (decision 2024-10-11) from Samsung Medison Co., Ltd. for a matching device line ("HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound System") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K241971

  • …and 8 more.

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/K223387