V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic Ultrasound System

K231772

Samsung Medison Co., Ltd. · cleared 2023-10-03 · product code IYN · Radiology

Premarket evidence — what FDA accepted

Device typehardware
source quote (p.4)
“The V8 / V7 / V6 / H8 / H7 / H6 are a general purpose, mobile, software controlled, diagnostic ultrasound system.”
AlgorithmAI algorithm used for all the new and improved AI-based features that includes expansion of the use of NerveTrack feature; NerveTrack segmentation function
source quote (p.7)
“These are the details on validation of the AI algorithm used for all the new and improved AI-based features that includes expansion of the use of NerveTrack feature and the information about the dataset the device was tested on. The proposed V8 / V7 / V6 / H8 / H7 / H6 have added the NerveTrack segmentation function that can be used for pre-injection only and cannot be used as a guide for needling based on similar indication for use of ScanNav Anatomy Peripheral Block (DEN220024) previously cleared.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (3)

Retrospective clinical

n=18 patients

endpoints: Accuracy (%); Speed (FPS)

Retrospective clinical

n=11 patients

endpoints: Accuracy (%); Speed (FPS)

Bench

sample size not stated

endpoints: acoustic output; biocompatibility; software function; cleaning and disinfection effectiveness; thermal safety; electrical safety; electromagnetic safety; mechanical safety

standards: AAMI ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD), IEC60601-1-2: 2020-09(4.1 Edition), Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - EMC, IEC 60601-2-37 Edition 2.0 2007, Medical electrical equipment – Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment, AAMI / ANSI / ISO 10993-1:2009/(R)2013, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process, ISO 14971:2019, 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 (2 observations)

accuracyas written: “Accuracy (%)”90.3CI 88.6 to 92.0
source quote (p.7)
“Accuracy (%) 90.3 88.6 to 92.0”
accuracyas written: “Accuracy (%)”98.69CI 96.31 to 100
source quote (p.8)
“Accuracy (%) 98.69 96.31 to 100”

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
11
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

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K250999 (decision 2025-07-18) from Samsung Medison Co., Ltd. for a matching device line ("V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System; V5 Diagnostic Ultrasound System; cV5 Diagnostic Ultrasound System; V4 Diagnostic Ultrasound System; cV4 Diagnostic Ultrasound System") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K250999

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K243702 (decision 2025-02-12) from Samsung Medison Co., Ltd. for a matching device line ("V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K243702

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K242511 (decision 2024-12-10) from Samsung Medison Co., Ltd. for a matching device line ("V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic Ultrasound System, XH5 Diagnostic Ultrasound System, V4 Diagnostic Ultrasound System, H4 Diagnostic Ultrasound System, XV4 Diagnostic Ultrasound System, XH4 Diagnostic Ultrasound System") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K242511

  • 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) K241971 (decision 2024-10-11) from Samsung Medison Co., Ltd. for a matching device line ("HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound System") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K241971

  • …and 5 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/K231772