DEEPECHO
K242594DeepEcho · cleared 2025-05-23 · product code IYN · Radiology
Premarket evidence — what FDA accepted
source quote (p.6)
“DEEPECHO is a cloud-based standalone software as a medical device (SaMD) that helps qualified healthcare professionals in the assessment of obstetrical images.”
source quote (p.9)
“Artificial Intelligence for biometric measurement computations”
Validation studies (1)
Reader study (MRMC)
n=397 patients · 15 site(s)
endpoints: Comparison of femur length; Comparison of head circumference; Comparison of abdominal circumference; Comparison of biparietal diameter; Sensitivity of each view identification; Specificity of each view identification
Reported performance (2 observations)
source quote (p.12)
“Abdominal View Sensitivity 442/508 86.9% (83.8% - 89.7%)”
source quote (p.12)
“Cephalic View Specificity 6482/6838 94.8% (94.2% - 95.3%)”
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).