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 |