AI4CMR V1.0

System, Image Processing, Radiological

AI4MedImaging Medical Solutions S.A.

The following data is part of a premarket notification filed by Ai4medimaging Medical Solutions S.a. with the FDA for Ai4cmr V1.0.

Pre-market Notification Details

Device IDK220624
510k NumberK220624
Device Name:AI4CMR V1.0
ClassificationSystem, Image Processing, Radiological
Applicant AI4MedImaging Medical Solutions S.A. Rua Do Parque Poente, Lote 35 Braga,  PT 4705-002
ContactCarla Almeida
CorrespondentCarla Almeida
AI4MedImaging Medical Solutions S.A. Rua Do Parque Poente, Lote 35 Braga,  PT 4705-002
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-03
Decision Date2022-07-22

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.