The following data is part of a premarket notification filed by Ai4medimaging Medical Solutions S.a. with the FDA for Ai4cmr V1.0.
| Device ID | K220624 |
| 510k Number | K220624 |
| Device Name: | AI4CMR V1.0 |
| Classification | System, Image Processing, Radiological |
| Applicant | AI4MedImaging Medical Solutions S.A. Rua Do Parque Poente, Lote 35 Braga, PT 4705-002 |
| Contact | Carla Almeida |
| Correspondent | Carla Almeida AI4MedImaging Medical Solutions S.A. Rua Do Parque Poente, Lote 35 Braga, PT 4705-002 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-03 |
| Decision Date | 2022-07-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05600250059022 | K220624 | 000 |