Clearance Summary
Annalise Enterprise CXR Triage Pneumothorax received FDA 510(k) clearance under submission number K213941, sponsored by Annalise-Ai. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2022-02-24.
- Submission: K213941
- Applicant / Sponsor: Annalise-Ai
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2080
- Decision date: 2022-02-24
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.