HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound System

K241971

Samsung Medison Co., Ltd. · cleared 2024-10-11 · product code IYN · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.5)
“The HERA Z20, R20, HERA Z30, R30 diagnostic ultrasound system are a general purpose, mobile, software controlled, diagnostic ultrasound system. Their function is to acquire ultrasound data and to display the data as 2D mode, Color Doppler mode, Power Doppler (PD) mode, M mode, Pulsed Wave (PW) Doppler mode, Continuous Wave (CW) Doppler mode, Tissue Doppler Imaging (TDI) mode, Tissue Doppler Wave (TDW) mode, ElastoScan Mode, Combined modes, MV-Flow mode, Multi-Image mode(Dual, Quad), 3D/4D mode. The proposed HERA Z20, R20, HERA Z30, R30 have included BiometryAssist, HeartAssist, ViewAssist previously cleared in the HERA W10/W9(K230084), based on AI technology, expanding the application as below,”
Algorithmdeep learning based quality assessment algorithm; deep learning based segmentation algorithm; deep learning based view recognition algorithm
source quote (p.6)
“The proposed HERA Z20, R20, HERA Z30, R30 have included BiometryAssist, HeartAssist, ViewAssist previously cleared in the HERA W10/W9(K230084), based on AI technology, expanding the application as below, a) ViewAssist, a cleared feature in the HERA W10/W9(K230084), has added additional annotation parts (profile, bladder, spine) and has subdivided the view recognitions items as below. A deep learning based quality assessment algorithm was validated using 3,900 fetal ultrasound images for each view. A deep learning based segmentation algorithm was validated using 450 sagittal uterus images collected at three hospitals. A deep learning based view recognition algorithm was validated using 1600 fetal ultrasound images and fetal biometry images collected at two hospitals. A deep learning based segmentation algorithm was validated using 360 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 (6)

Retrospective clinical

n=3,900 images

endpoints: Quality assessment ('acceptable' or 'not-acceptable'); Cohen's kappa coefficient; average speed

Retrospective clinical

n=200 scans

endpoints: acceptance rate; mean DSC

Retrospective clinical

n=450 images · 3 site(s)

endpoints: average dice-score of uterus; average dice-score of endometrium; proportion of appropriateness clinically diagnosable

Retrospective clinical

n=1,600 images · 2 site(s)

endpoints: average recognition accuracy; average dice-score

Retrospective clinical

n=440 images

endpoints: average recognition accuracy; average 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=360 images · 2 site(s)

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

Reported performance (20 observations)

agreement_kappaas written: “average Cohen's kappa coefficient”0.818
source quote (p.9)
“The average Cohen's kappa coefficient is 0.818 (threshold 0.7)”
diceas written: “Mean DSC Fluid (1st trimester)”0.96
source quote (p.10)
“Fluid 0.96”
diceas written: “Mean DSC Fetus (1st trimester)”0.91
source quote (p.10)
“Fetus 0.91”
diceas written: “Mean DSC Umbilical-cord (1st trimester)”0.68
source quote (p.10)
“Umbilical-cord 0.68”
diceas written: “Mean DSC Placenta (1st trimester)”0.74
source quote (p.10)
“Placenta 0.74”
diceas written: “Mean DSC Uterus (1st trimester)”0.93
source quote (p.10)
“Uterus 0.93”
diceas written: “Mean DSC for accepted cases Fluid (2nd/3rd trimester)”0.78
source quote (p.11)
“Fluid 0.78”
diceas written: “Mean DSC for accepted cases Head (2nd/3rd trimester)”0.94
source quote (p.11)
“Head 0.94”
diceas written: “Mean DSC for accepted cases Body (2nd/3rd trimester)”0.68
source quote (p.11)
“Body 0.68”
diceas written: “Mean DSC for accepted cases Umbilical-cord (2nd/3rd trimester)”0.67
source quote (p.11)
“Umbilical-cord 0.67”
diceas written: “Mean DSC for accepted cases Limbs (2nd/3rd trimester)”0.66
source quote (p.11)
“Limbs 0.66”
diceas written: “Mean DSC for accepted cases Placenta (2nd/3rd trimester)”0.75
source quote (p.11)
“Placenta 0.75”
diceas written: “Mean DSC for accepted cases Uterus (2nd/3rd trimester)”0.8
source quote (p.11)
“Uterus 0.80”
diceas written: “average dice-score of uterus”0.96
source quote (p.12)
“The average dice-score of uterus is 96%”
diceas written: “average dice-score of endometrium”0.92
source quote (p.12)
“The average dice-score of endometrium is 92%”
accuracyas written: “average recognition accuracy”94.5
source quote (p.13)
“The average recognition accuracy is 94.50% (threshold 89%)”
diceas written: “average dice-score”0.892
source quote (p.13)
“The average dice-score is 0.892 (threshold 0.8)”
accuracyas written: “average recognition accuracy”95
source quote (p.14)
“The average recognition accuracy is 95.00% (threshold 89%)”
diceas written: “average dice-score”0.876
source quote (p.14)
“The average dice-score is 0.876 (threshold 0.8)”
diceas written: “average dice-score”0.928
source quote (p.15)
“The average dice-score is 0.928 (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
5
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

  • 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/K241971