Devices · AI4MedImaging Medical Solutions S.A.
AI4CMR v1.0
510(k)K220624RadiologyLLZ
AI4MedImaging Medical Solutions S.A. is listed for AI4CMR v1.0 (K220624). The FDA list gives July 22, 2022 as the date of the final decision. The lead panel is Radiology, and the database link on the FDA list is the 510(k) pathway. The primary product code on the FDA list is LLZ. openFDA did not return a classification record for that code in this copy of the data. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K220624
- Date of final decision
- July 22, 2022
- Company on the FDA list
- AI4MedImaging Medical Solutions S.A.
- Lead panel
- Radiology
- Primary product code
- LLZ
- openFDA device name for the code
- System, Image Processing, Radiological
- Device class
- 2
- Regulation number
- 892.2050
- openFDA decision description
- Substantially Equivalent
- openFDA decision code
- SESE
- Statement or summary label
- Summary