HERA W9, HERA W10 Diagnostic Ultrasound System

K211824

Samsung Medison Co., Ltd. · cleared 2021-09-09 · product code IYN · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.4)
“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 proposed HERA W9/ HERA W10 added new SW features AI based HeartAssist(HERA W10 only), and ViewAssist. It provides similar functionality to SonoLystIR in predicate Voluson SWIFT (K201828). HeartAssist is a deep learning based function that provides classification of ultrasound image into measurement views required for fetal heart scanning and provides measurement results. BiometryAssist, a feature based on deep learning technology, is an automatic technology for biometric measurement which can be edited by the user.”
AlgorithmDeep learning based AI algorithms for HeartAssist, ViewAssist, and BiometryAssist
source quote (p.7)
“The proposed HERA W9/ HERA W10 added new SW features AI based HeartAssist(HERA W10 only), and ViewAssist. HeartAssist is a deep learning based function that provides classification of ultrasound image into measurement views required for fetal heart scanning and provides measurement results. ViewAssist is a deep learning based function that provides classification of ultrasound image into key scanning views and provides annotations. The proposed HERA W9/ HERA W10 implemented an Al version of BiometryAssist which improved from previously cleared function BiometryAssist in predicate HERA W9/ HERA W10 (K192319). BiometryAssist, a feature based on deep learning technology, is an automatic technology for biometric measurement which can be edited by the user.”
Adaptive (vs locked)No
source quote (p.7)
“HeartAssist is a deep learning based function that provides classification of ultrasound image into measurement views required for fetal heart scanning and provides measurement results. The feature recognizes views and proposes caliper placements and corresponding measurements allowing users to save time and increase examination efficiency through reducing key-strokes and proposing measurements which can be edited by the user. BiometryAssist, a feature based on deep learning technology, is an automatic technology for biometric measurement which can be edited by the user.”
PCCPNo
Cybersecurity addressedNo

Validation studies (1)

Bench

sample size not stated

endpoints: acoustic output evaluation; biocompatibility evaluation; cleaning and disinfection effectiveness evaluation; thermal safety evaluation; electrical safety evaluation; electromagnetic safety evaluation; mechanical safety evaluation; risk analysis and mitigation; software verification and validation testing; system verification and validation testing; image quality tests; passing results for pre-defined testing criteria for new software functions; measurement accuracy requirements for improved BiometryAssist

standards: ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010 /(R)2012, IEC60601-1-2: 2014(4th Edition), IEC60601-2-37:2007 + A1:2015, ISO 10993-1, ISO 14971:2007, NEMA UD 2-2004 (R2009)

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

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
9
drift signals on this device
  • 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) K230084 (decision 2023-04-21) 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:K230084

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K223387 (decision 2023-02-13) from Samsung Medison Co., Ltd. for a matching device line ("V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K223387

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K220975 (decision 2022-06-29) from Samsung Medison Co., Ltd. for a matching device line ("V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K220975

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K220043 (decision 2022-04-05) 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:K220043

  • 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

  • …and 3 more.

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/K211824