KA Imaging Inc

Address:560 Parkside Drive #3,Waterloo Ontario,CA

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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

Solid State X-Ray Imager (Flat Panel/Digital Imager) (MQB) (1)

Premarket Exempt

Clear

Reveal 35C - 16280119411015 Catalog Number : 101

Device Description : The flat panel detector, when used with a radiographic imaging system, is intend The flat panel detector, when used with a radiographic imaging system, is intended to generate radiographic images of human anatomy wherever a conventional screen-film, digital radiography (DR) or computed radiography (CR) detector is used for general purposes.

Device Class : 2

Duns Number: 203337746

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

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