HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound System
K220043Samsung Medison Co., LTD · cleared 2022-04-05 · product code IYN · Radiology
Premarket evidence — what FDA accepted
source quote (p.6)
“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)”
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)”
Validation studies (1)
Bench
sample size not stated
endpoints: acoustic output; biocompatibility; cleaning and disinfection effectiveness; thermal safety; electrical safety; electromagnetic safety; mechanical safety; risk analysis and mitigation; 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, Medical Electrical Equipment - Part 1: General Requirements for basic safety and essential performance., IEC60601-1-2: 2014(4th Edition), Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - EMC, IEC60601-2-37:2007 + A1:2015, Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment, ISO 10993-1, Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process., ISO 14971:2007, Medical devices - Application of risk management to medical devices, NEMA UD 2-2004 (R2009), Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3
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
- 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). 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).