510(k) K250959
K250959 is an FDA 510(k) premarket notification submitted by Bioticsai, Inc. for the device "BioticsAI". The FDA issued a decision of Substantially Equivalent on Dec 22, 2025. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 22, 2025
- Date Received
- Mar 31, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Imaging, Pulsed Doppler, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 892.1550
- Review Panel
- RA
- Submission Type