HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound System

K220043

Samsung Medison Co., LTD · cleared 2022-04-05 · 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. The proposed HERA W9/ HERA W10 have expanded the measurement parts of BiometryAssist (AI version) in the previously cleared HERA W9/ HERA W10 (K211824). The proposed HERA W9/ HERA W10 have expanded the view recognition and the annotation of ViewAssist (AI version) in the previously cleared HERA W9/ HERA W10 (K211824)”
AlgorithmAI version for BiometryAssist and ViewAssist
source quote (p.6)
“The proposed HERA W9/ HERA W10 have expanded the measurement parts of BiometryAssist (AI version) in the previously cleared HERA W9/ HERA W10 (K211824). The proposed HERA W9/ HERA W10 have expanded the view recognition and the annotation of ViewAssist (AI version) in the previously cleared HERA W9/ HERA W10 (K211824)”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (1)

Bench

sample size not stated

endpoints: acoustic output; biocompatibility; cleaning and disinfection effectiveness; thermal, electrical, electromagnetic and mechanical safety; Software verification and validation testing; System verification and validation testing; Image quality tests

standards: ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010 /(R)2012, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO10993-1, ISO14971, NEMA UD 2-2004

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) K231772 (decision 2023-10-03) from Samsung Medison Co., Ltd. for a matching device line ("V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic Ultrasound System") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K231772

  • 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

  • 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/K220043