Digital Color Doppler Ultrasound System (P60 Series)
K241949Sonoscape Medical Corp. · cleared 2025-01-17 · product code IYN · Radiology
Premarket evidence — what FDA accepted
source quote (p.6)
“This SonoScape P60 Series Digital Color Doppler Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The P60 Series Digital Color Doppler Ultrasound System add one new feature: S-FetusAI, which is carried out using the Artificial Intelligence or Machine Learning algorithm.”
source quote (p.9)
“The P60 Series Digital Color Doppler Ultrasound System add one new feature: S-FetusAI, which is carried out using the Artificial Intelligence or Machine Learning algorithm.”
Validation studies (2)
Standalone
n=3,717 images · 3 site(s)
standards: AAMI/ANSI ES 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, AIUM/NEMA UD 2
Retrospective clinical
n=158 cases
endpoints: 1.Identification Precision of the 14 Standard Sections (Primary Evaluation Indicator); 2. Measurement Error of Growth Parameters (Secondary Evaluation Indicator); 1) The relative errors of measurement for the 11 Growth Parameters;; 2) The precision of Sp (spinal cord cone end positioning).
Reported performance (4 observations)
source quote (p.8)
“The accuracy of the S-Fetus-Recognition is 90.01%.”
source quote (p.8)
“The accuracy of the S-fetus-Measure is 85%.”
source quote (p.8)
“According to the clinical trial results, we can deduce that the recognition precision of the standard sections of S-FetusAI was not inferior to that of the manual scan, S-FetusAI has a good consistency with the manual measurement and the Sp (spinal cone end positioning) precision was basically equal between the trial group and control group.”
source quote (p.8)
“According to the clinical trial results, we can deduce that the recognition precision of the standard sections of S-FetusAI was not inferior to that of the manual scan, S-FetusAI has a good consistency with the manual measurement and the Sp (spinal cone end positioning) precision was basically equal between the trial group and control group.”
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).