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) (5) Cassette, radiographic film (IXA) (4) Film, radiographic (IWZ) (2) Full field digital,system,x-ray,mammographic (MUE) (1)

Premarket Exempt

No Yes

Clear

DRYVIEW DVC Laser Imaging Film - 60889978795246 Catalog Number : 8795247

Device Description : 125SH 35X43CM (14X17IN) DVC CE SBOX

Device Class :

Duns Number: 793169512

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 125

LANEX Regular Screens - 60889978802098 Catalog Number : 8802092

Device Description : LANEX Regular SCR 20PR 4.88x14.75in H-G

Device Class :

Duns Number: 793169512

Premarket Exempt : Yes

Product Code : EAM

Prescription Use : No

Device Count : 20

MIN-R 2 Cassette with MIN-R EV 190 Screen - 60889978806324 Catalog Number : 8806325

Device Description : 24X30CM MIN-R2 CASS W/EV 190 SCR

Device Class : 1

Duns Number: 793169512

Premarket Exempt : No

Product Code : EAM, IXA

Prescription Use : No

Device Count : 1

DIRECTVIEW CR Cassette with PQ Screen - 60889978824601 Catalog Number : 8824609

Device Description : 35x43CM DV CR REPLACMT PLATE/PQ SCR

Device Class : 1

Duns Number: 793169512

Premarket Exempt : Yes

Product Code : EAM

Prescription Use : No

Device Count : 1

MIN-R EV 150 Screen - 60889978838332 Catalog Number : 8838336

Device Description : SGL 18X24CM MINR EV150 S WO FM FOEM

Device Class : 1

Duns Number: 793169512

Premarket Exempt : Yes

Product Code : EAM

Prescription Use : No

Device Count : 1

RP X-OMAT LO Fixer and Replenisher - 60889978868803 Catalog Number : 8868804

Device Description : RP X-OMAT FIXER AND REPLENISHER 10GL

Device Class : 1

Duns Number: 793169512

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 1

DIRECTVIEW CR Mammography Cassette with EHR-M3 Screen - 60889978869848 Catalog Number : 8869844

Device Description : 24X30CM CR MAMMO SCR EHR-M3

Device Class : 2

Duns Number: 793169512

Premarket Exempt : No

Product Code : MUE

Prescription Use : Yes

Device Count : 1

MIN-R 2 Cassette with MIN-R 2190 Screen - 60889978910854 Catalog Number : 8910853

Device Description : 24X30CM MIN-R2 CASS W/MINR 2190 SCR

Device Class : 1

Duns Number: 793169512

Premarket Exempt : No

Product Code : IXA, EAM

Prescription Use : No

Device Count : 1

DIRECTVIEW CR Cassette with PQ Screen - 60889978933884 Catalog Number : 8933889

Device Description : SGL 35X35CM DIRECTVIEW PQ SCR

Device Class : 2

Duns Number: 793169512

Premarket Exempt : No

Product Code : IXA

Prescription Use : No

Device Count : 1

CR Cassettes for Vita Systems - 60889978964390 Catalog Number : 8964397

Device Description : CARESTREAM CR Cassette 25x30/10x12

Device Class : 2

Duns Number: 793169512

Premarket Exempt : No

Product Code : IXA

Prescription Use : Yes

Device Count : 1

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