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. Its function is to acquire ultrasound data and to display the data as B-mode, M-mode, Pulsed wave (PW) Doppler, Continuous wave (CW) Doppler, Color Doppler, Tissue Doppler Imaging (TDI), Tissue Doppler Wave (TDW), Power Amplitude Doppler, Pulse Inversion Harmonic Imaging (S- Harmonic), Directional Power Doppler (S-Flow), Color M-Mode, 3D Imaging Mode, 4D Imaging Mode, Elastoscan+ Mode, Tissue Harmonic Imaging, MV-Flow Mode or as a combination of these modes. The HERA W9/HERA W10 also give the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The HERA W9/HERA W10 have real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed. 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.”
Algorithmdeep learning based view recognition algorithm; deep learning based segmentation algorithm
source quote (p.8)
“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).”
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=69 patients · 2 site(s)

endpoints: 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

Retrospective clinical

n=33 patients · 2 site(s)

endpoints: dice-score; error rate of circumference measured value; error rate of distance measured value; error rate of NT, NB and IT measured value

Retrospective clinical

n=98 patients · 2 site(s)

endpoints: recognition accuracy; dice-score

Standalone

sample size not stated

endpoints: matched the performance of local ultrasound systems

Reported performance (5 observations)

accuracyas written: “average recognition accuracy”96.07
source quote (p.8)
“The average recognition accuracy is 96.07% (threshold 89%)”
diceas written: “average dice-score”0.88
source quote (p.8)
“The average dice-score is 0.88 (threshold 0.8).”
diceas written: “average dice-score”0.91
source quote (p.9)
“The average dice-score is 0.91 (threshold 0.8)”
accuracyas written: “average recognition accuracy”94.92
source quote (p.11)
“The average recognition accuracy is 94.92% (threshold 89%)”
diceas written: “average 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

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/K242444