Clearance Summary
1CMR Pro received FDA 510(k) clearance under submission number K242062, sponsored by Mycardium AI Limited. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2024-11-15.
- Submission: K242062
- Applicant / Sponsor: Mycardium AI Limited
- Clearance pathway: Abbreviated
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2024-11-15
Classification & Regulation
This clearance is catalogued under FDA product code LLZ and 21 CFR 892.2050, within the Radiology review panel as a Class II device.