Videahealth, Inc.

Address:179 South Street,Boston,MA,02111,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Analyzer, Medical Image (MYN) (1)

Premarket Exempt

Clear

Videa Caries Assist - 00196852162192 Catalog Number :

Device Description : Videa Caries Assist is a computer-assisted detection (CADe) device that analyzes Videa Caries Assist is a computer-assisted detection (CADe) device that analyzes intraoral radiographs to identify and localize carious lesions.Videa Caries Assist is indicated for the review of bitewing (BW) radiographs acquired from adult patients aged 22 years or older.

Device Class : 2

Duns Number: 117170604

Premarket Exempt : No

Product Code : MYN

Prescription Use : Yes

Device Count : 1

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