V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System

K243702

Samsung Medison Co., Ltd. · cleared 2025-02-12 · product code IYN · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.5)
“The V8/cV8, V7/cV7,V6/cV6 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 proposed_V8/cV8, V7/cV7,V6/cV6_have included ‘EzNerveMeasure' previously cleared in the predicate RS85 (K240516), as a sub-function of NerveTrack based on AI technology.”
Algorithmdeep learning-based segmentation algorithm; AI technology
source quote (p.6)
“The proposed_V8/cV8, V7/cV7,V6/cV6_have included ‘EzNerveMeasure' previously cleared in the predicate RS85 (K240516), as a sub-function of NerveTrack based on AI technology. A deep learning-based segmentation algorithm was validated using 100 median nerve images collected at a hospital.”
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)

Standalone

n=100 images · 1 site(s)

endpoints: flattening ratio (FR); cross-sectional area (CSA)

standards: AAMI ANSI ES60601-1:2005/(R)2012 & A1:2012 C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021], IEC60601-1-2:2014 [Including AMD 1:2021], IEC 60601-2-37 Edition 2.1 2015, IEC TR 60601-4-2 Edition 1.0 2016-05, AAMI / ANSI / ISO 10993-1:2018, ISO 14971:2019, 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

85
recalls in product code, 24mo
554
MAUDE reports in code, 12mo
+85%
vs code's own 3-yr baseline
5
drift signals on this device
  • 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

  • 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

  • recall_reason_pattern

    Software/algorithm-related recall in product code IYN (GE Medical Systems, LLC, initiated 2025-09-18): "The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinica" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:97726

  • recall_reason_pattern

    Software/algorithm-related recall in product code IYN (GE Medical Systems China Co., Ltd. Dev. Zone National Hi-Tech; No., initiated 2025-05-16): "GE HealthCare has become aware that the Estimated Fetal Weight (EFW) measurement data feature on the Versana Premier R3 and LOGIQ F R3 series ultrasound systems can display previou" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:96992

  • recall_reason_pattern

    Software/algorithm-related recall in product code IYN (Siemens Medical Solutions USA, Inc., initiated 2024-08-15): "If ultrasound systems with software, are changed from factory default to : 1) Milliliters per second (ml/sec, mL/sec) or 2) Milliliters per minute (ml/min, mL/min); then systems wi" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:95254

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/K243702