fda
2 records
FDA Recall: Diagnos Inc — Class II
20220406
Retinal analysis system software has some features, based on artificial intelligence, that potentially lack appropriate market approval, so it is reco | Product: CARA (Computer Assisted Retinal Analys...
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FDA Device Recall: CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D
2022-04-06
Class II — Retinal analysis system software has some features, based on artificial intelligence, that potentially lack appropriate market approval, so it is recommended to use a specific prior softwar...
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nppes
1 records
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