Clearance Summary
Annalise Enterprise received FDA 510(k) clearance under submission number K250831, sponsored by Annalise-Ai. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2025-04-23.
- Submission: K250831
- Applicant / Sponsor: Annalise-Ai
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2080
- Decision date: 2025-04-23
Classification & Regulation
This clearance is catalogued under FDA product code QFM and 21 CFR 892.2080, within the Radiology review panel as a Class II device.