BioticsAI

K250959

Bioticsai, Inc. · cleared 2025-12-22 · product code IYN · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.6)
“BioticsAI is a software used by OB/GYN care centers for prenatal ultrasound review and reporting. 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. It serves as concurrent reading aid for ultrasound images both during and after a fetal anatomical ultrasound examination.”
AlgorithmArtificial Intelligence (Computer Vision) with three primary AI components: High-Level Anatomy Classification, Per-Class Top-1 Fetal Plane Classification, and Fetal Anatomical Structure Classification.
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. Algorithm Methodology Artificial Intelligence (Computer Vision)”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.12)
“Cybersecurity testing”

Validation studies (1)

Retrospective clinical

n=296 patients · 1 site(s)

endpoints: Sensitivity; Specificity

Reported performance (8 observations)

sensitivity0.934CI (0.929, 0.94)
source quote (p.15)
“0.934 (0.929, 0.94)”
specificity0.989CI (0.988, 0.99)
source quote (p.15)
“0.989 (0.988, 0.99)”
sensitivityas written: “AI-1 High Level Anatomy: Fetal "Abdomen" View Sensitivity”0.953CI (0.942, 0.962)
source quote (p.13)
“0.953 (0.942, 0.962)”
specificityas written: “AI-1 High Level Anatomy: Fetal "Abdomen" View Specificity”0.986CI (0.984, 0.989)
source quote (p.13)
“0.986 (0.984, 0.989)”
sensitivityas written: “AI-2: Per-Class Top-1 Fetal Plane Classification - abdomen bladder Sensitivity”0.96CI (0.940, 0.977)
source quote (p.14)
“0.960 (0.940, 0.977)”
specificityas written: “AI-2: Per-Class Top-1 Fetal Plane Classification - abdomen bladder Specificity”0.998CI (0.997, 0.998)
source quote (p.14)
“0.998 (0.997, 0.998)”
sensitivityas written: “AI-3: Fetal Anatomical Structure Classification - Automatic detection of 12 fetal head anatomical structures Sensitivity Across all Image Qualities”0.881CI (0.871, 0.891)
source quote (p.15)
“0.881 (0.871, 0.891)”
specificityas written: “AI-3: Fetal Anatomical Structure Classification - Automatic detection of 12 fetal head anatomical structures Specificity Across all Image Qualities”0.991CI (0.99, 0.992)
source quote (p.15)
“0.991 (0.99, 0.992)”

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/K250959