V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound System
K240631Samsung Medison Co., Ltd. · cleared 2024-06-21 · product code IYN · Radiology
Premarket evidence — what FDA accepted
source quote (p.4)
“The V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 diagnostic ultrasound system are a general purpose, mobile, software controlled, diagnostic ultrasound system.”
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.”
source quote (p.1)
“Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).”
Validation studies (3)
Retrospective clinical
n=1,000 images
endpoints: Accuracy (%); Speed (FPS)
Retrospective clinical
n=1,000 images
endpoints: Accuracy (%); Speed (FPS)
Bench
sample size not stated
endpoints: assess whether remote viewing and reviewing with SonoSync matched the performance of local ultrasound systems
Reported performance (2 observations)
source quote (p.7)
“Accuracy (%) Average 90.3 Standard Deviation 4.88 95% CI 87.28 to 93.33”
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
- 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). 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).