Clearance Summary
AI4CMR v2.0 received FDA 510(k) clearance under submission number K252084, sponsored by Ai4medimaging Medical Solutions S.A.. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2026-02-11.
- Submission: K252084
- Applicant / Sponsor: Ai4medimaging Medical Solutions S.A.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2026-02-11
Classification & Regulation
This clearance is catalogued under FDA product code QIH and 21 CFR 892.2050, within the Radiology review panel as a Class II device.