HS40 Diagnostic Ultrasound System

K221599

Samsung Medison Co., Ltd. · cleared 2022-08-22 · product code IYN · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.5)
“The proposed HS40 has added the UterineAssist based on AI already cleared in the predicate devce V8(K211945) and expanded the detection nerve type (Elbow : MN, UN, RN / Neck&Shoulder : ISBP, SCBP, AxBP) of NerveTrack based on AI in the previously cleared HS40(K210426).”
AlgorithmAI algorithm for NerveTrack; deep learning based segmentation algorithm for UterineAssist
source quote (p.7)
“These are the details on validation of the AI algorithm used for all the new and improved Al-based features that includes expansion of the use of NerveTrack feature and the information about the dataset the device was tested on. A deep learning based segmentation algorithm was validated using 450 sagittal uterus images and 150 transverse uterus images collected at three 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 (2)

Standalone

n=18 patients

endpoints: Accuracy (%); Speed (FPS)

Standalone

n=600 images · 3 site(s)

endpoints: average dice-score of uterus; average dice-score of endometrium; errors of uterus feature points; errors of endometrium feature points; errors of Measurements performance

Reported performance (4 observations)

accuracyas written: “Accuracy (%)”91.7CI 89.5 to 93.9
source quote (p.7)
“Accuracy (%): Average 91.7, 95% CI 89.5 to 93.9”
diceas written: “average dice-score of uterus”96
source quote (p.8)
“The average dice-score of uterus is 96%”
diceas written: “average dice-score of endometrium”92
source quote (p.8)
“The average dice-score of endometrium is 92%”
f1as written: “errors of Measurements performance”2
source quote (p.8)
“The errors of Measurements performance are 2.0 mm or less”

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/K221599