V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System

K220975

Samsung Medison Co., Ltd. · cleared 2022-06-29 · product code IYN · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.4)
“The V8 / V7 are a general purpose, mobile, software controlled, diagnostic ultrasound system. Its 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, Multi-Image mode(Dual, Quad), 3D/4D mode. The proposed V8 / V7 have expanded the detection nerve type (Elbow : MN, UN, RN / Neck&Shoulder : ISBP, SCBP, AxBP) of NerveTrack based on AI in the previously cleared V8 (K211945).”
AlgorithmAI algorithm for NerveTrack feature
source quote (p.6)
“The validation for expansion of the detection nerve of NerveTrack based on AI. This is 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.”
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)

Retrospective clinical

n=18 patients

endpoints: Accuracy (%); Speed (FPS)

standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, ISO 14971, NEMA UD 2-2004

Reported performance (1 observation)

accuracyas written: “Accuracy (%)”91.7CI 89.5 to 93.9
source quote (p.7)
“Accuracy (%) 91.7 5.6 89.5 to 93.9”

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
15
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 9 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).

RIGOR™ Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: radar.healthai.com/precedent/device/K220975