HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System

K242444

Samsung Medison Co., Ltd. · cleared 2024-11-27 · product code IYN · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml

source quote (p.5)

“The HERA W9/ HERA W10 are general purpose, mobile, software controlled, diagnostic ultrasound system. The proposed HERA W9/HERA W10 have expanded the measurement items of NB(Nasal Bone), IT(Intracranial Translucency) in the MSP(Mid-Sagittal Plane) view of BiometryAssist based on the AI technology.”

AlgorithmAI technology, deep learning based view recognition algorithm, deep learning based segmentation algorithm

source quote (p.6)

“The proposed HERA W9/HERA W10 have expanded the measurement items of NB(Nasal Bone), IT(Intracranial Translucency) in the MSP(Mid-Sagittal Plane) view of BiometryAssist based on the AI technology. The proposed HERA W9/ HERA W10 have improved the performance of ViewAssist through algorithm change based on the AI technology. The proposed HERA W9/ HERA W10 have improved the performance of HeartAssist through algorithm change based on the AI technology. A deep learning based view recognition algorithm was validated using 280 fetal heart images collected at two hospitals. A deep learning based segmentation algorithm was validated using 320 fetal biometry images collected at two hospitals (South Korea and United States). A deep learning based view recognition algorithm was validated using 1,320 fetal heart and fetal biometry images collected at two hospitals (South Korea and United States). A deep learning based segmentation algorithm was validated using 1,320 fetal heart and 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 (8)

Retrospective clinical

n=280 images · 2 site(s)

endpoints: average recognition accuracy

Retrospective clinical

n=280 images · 2 site(s)

endpoints: average dice-score

Retrospective clinical

n=280 images · 2 site(s)

endpoints: error rate of area measured value; error rate of angle measured value; error rate of circumference measured value; error rate of diameter measured value

Retrospective clinical

n=320 images · 2 site(s)

endpoints: average dice-score

Retrospective clinical

n=320 images · 2 site(s)

endpoints: error rate of circumference measured value; error rate of distance measured value

Retrospective clinical

n=1,320 images · 2 site(s)

endpoints: average recognition accuracy

Retrospective clinical

n=1,320 images · 2 site(s)

endpoints: average dice-score

Bench

sample size not stated

endpoints: matched the performance of local ultrasound systems

Reported performance (5 observations)

accuracyas written: “HeartAssist - View recognition accuracy”0.9607

source quote (p.8)

“The average recognition accuracy is 96.07% (threshold 89%)”

diceas written: “HeartAssist - Segmentation dice-score”0.88

source quote (p.8)

“The average dice-score is 0.88 (threshold 0.8).”

diceas written: “BiometryAssist - Segmentation dice-score”0.91

source quote (p.9)

“The average dice-score is 0.91 (threshold 0.8)”

accuracyas written: “ViewAssist - View recognition accuracy”0.9492

source quote (p.11)

“The average recognition accuracy is 94.92% (threshold 89%)”

diceas written: “ViewAssist - Anatomy annotation(segmentation) dice-score”0.89

source quote (p.11)

“The average dice-score is 0.89 (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

recalls in product code, 24mo

554

MAUDE reports in code, 12mo

+85%

vs code's own 3-yr baseline

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).