V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound System

K240631

Samsung Medison Co., Ltd. · cleared 2024-06-21 · product code IYN · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.5)
“The proposed V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 diagnostic ultrasound system has expanded the applications of NerveTrack Segmentation previously cleared in the predicate V8/H8, V7/H7, V6/H6(K231772) diagnostic ultrasound system based on AI technology.”
AlgorithmAI 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/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 diagnostic ultrasound system has expanded the applications of NerveTrack Segmentation previously cleared in the predicate V8/H8, V7/H7, V6/H6(K231772) diagnostic ultrasound system based on AI technology.
source quote (p.5)
“The proposed V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 diagnostic ultrasound system has expanded the applications of NerveTrack Segmentation previously cleared in the predicate V8/H8, V7/H7, V6/H6(K231772) diagnostic ultrasound system based on AI technology. 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 addressedFDA source did not state this

Validation studies (1)

Bench

n=1,000 cases

endpoints: Accuracy (%); Speed (FPS)

standards: AAMI ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(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, IEC TR 60601-4-2 Edition 1.0 2016-05, Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems, 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 87.28 to 93.33
source quote (p.7)
“Accuracy (%) Average 90.3 Standard Deviation 4.88 95% CI 87.28 to 93.33”
accuracyas written: “Accuracy (%)”98.42CI 97.13 to 99.71
source quote (p.8)
“Accuracy (%) Average 98.42 Standard Deviation 3.99 95% CI 97.13 to 99.71”

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
4
drift signals on this device
  • 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/K240631