BioticsAI
K250959Bioticsai, Inc. · cleared 2025-12-22 · product code IYN · Radiology
Premarket evidence — what FDA accepted
source quote (p.6)
“BioticsAI is a Software as a Service (SaaS) solution that aims at helping sonographers, OB/GYNs, MFMs and Fetal surgeons (all three designated as healthcare professionals i.e. HCP) to perform their routine fetal ultrasound examinations in real-time.”
source quote (p.6)
“BioticsAI uses artificial intelligence (A.I.) to automatically annotate ultrasound images with fetal anatomical planes and structures to facilitate ultrasound review and report generation for fetal ultrasound anatomical scans.”
source quote (p.12)
“Cybersecurity testing”
Validation studies (1)
Standalone
n=11,186 images · 1 site(s)
endpoints: Sensitivity Across Diagnostically Acceptable Images; Sensitivity Across all Image Qualities; Specificity Across all Image Qualities
Reported performance (4 observations)
source quote (p.15)
“Automatic detection of 5 High-Level Fetal Anatomy Sections (Abdomen, Face, Head, Limbs, Thorax) ... 0.934 (0.929, 0.94)”
source quote (p.15)
“Automatic detection of 5 High-Level Fetal Anatomy Sections (Abdomen, Face, Head, Limbs, Thorax) ... 0.989 (0.988, 0.99)”
source quote (p.15)
“Automatic detection of 13 fetal ultrasound planes (Per-class Top-1 classification) ... 0.960 (0.955, 0.964)”
source quote (p.15)
“Automatic detection of 13 fetal ultrasound planes (Per-class Top-1 classification) ... 0.997 (0.997, 0.998)”
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).