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 with ml

source quote (p.4)

“The V8 / V7 / V6 / H8 / H7 / H6 are a general purpose, mobile, software controlled, diagnostic ultrasound system. Their 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 V8 / V7 / V6 / H8 / H7 / H6 also give the operator the ability to measure anatomical structures and offer analysis packages that provide information that is used to make a diagnosis by competent health care professionals. 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.”

AlgorithmAI algorithm used for all the new and improved AI-based features that includes expansion of the use of NerveTrack feature

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.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedNo

Validation studies (2)

Retrospective clinical

n=2,146 images

endpoints: Accuracy (%); Speed (FPS)

Retrospective clinical

n=3,836 images

endpoints: Accuracy (%); Speed (FPS)

Reported performance (2 observations)

accuracyas written: “Accuracy (%)”90.3CI 88.6 to 92.0

source quote (p.7)

“Accuracy (%) Average 90.3 Standard Deviation 4.8 95% CI 88.6 to 92.0”

accuracyas written: “Accuracy (%)”98.69CI 96.31 to 100

source quote (p.8)

“Accuracy (%) Average 98.69 Standard Deviation 0.64 95% CI 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

recalls in product code, 24mo

554

MAUDE reports in code, 12mo

+85%

vs code's own 3-yr baseline

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). 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).