510(k) K220624
K220624 is an FDA 510(k) premarket notification submitted by Ai4Medimaging Medical Solutions S.A. for the device "AI4CMR v1.0". The FDA issued a decision of Substantially Equivalent on Jul 22, 2022. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Ai4Medimaging Medical Solutions S.A. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 22, 2022
- Date Received
- Mar 3, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Image Processing, Radiological
- Device Class
- Class II
- Regulation Number
- 892.2050
- Review Panel
- RA
- Submission Type