CARESTREAM HEALTH, INC.

Address:1049 West Ridge Road,Rochester,NY,14615,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

Screen, intensifying, radiographic (EAM) (2) Cassette, radiographic film (IXA) (1) Solid state x-ray imager (flat panel/digital imager) (MQB) (1)

Premarket Exempt

No Yes

Clear

Elite CR System - 60889978981311 Catalog Number : 8981318

Device Description : Elite CR System W/WP

Device Class : 2

Duns Number: 793169512

Premarket Exempt : No

Product Code : MQB

Prescription Use : No

Device Count : 1

EV Screens - 60889978997329 Catalog Number : 8997322

Device Description : EV SCR 1PR 8x10in NF

Device Class : 1

Duns Number: 793169512

Premarket Exempt : Yes

Product Code : EAM

Prescription Use : No

Device Count : 1

MIN-R 2 Cassette with MIN-R 2000 Screen - 60889978999491 Catalog Number : 8999492

Device Description : 24X30CM MIN-R2 CASS W/MINR 2000 SCR

Device Class : 1

Duns Number: 793169512

Premarket Exempt : No

Product Code : IXA, EAM

Prescription Use : No

Device Count : 1

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