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

Film, radiographic (IWZ) (7) Cassette, radiographic film (IXA) (1) Full field digital,system,x-ray,mammographic (MUE) (1) Screen, intensifying, radiographic (EAM) (1)

Premarket Exempt

No Yes

Clear

Ultra-speed - 40889971228938 Catalog Number : 1228931

Device Description : Ultra-speed 100PKT 22x35 film DF53

Device Class :

Duns Number: 793169512

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 100

Half Blue X-ray Film WB - 40889971246369 Catalog Number : 1246362

Device Description : 100SH 35X43-14X17 HALF BLUE X-RAY

Device Class :

Duns Number: 793169512

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 100

DRYVIEW DVC Laser Imaging Film - 40889971253985 Catalog Number : 1253988

Device Description : 125SH 35X35CM (14X14IN) DVC CE

Device Class :

Duns Number: 793169512

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 125

LANEX Fine Screens - 40889971267623 Catalog Number : 1267624

Device Description : PR 18X24CM LANEX FINE SCREEN C1

Device Class : 1

Duns Number: 793169512

Premarket Exempt : Yes

Product Code : EAM

Prescription Use : No

Device Count : 1

DIRECTVIEW CR Cassette with HR Screen - 40889971269672 Catalog Number : 1269679

Device Description : DIRECTVIEW CR Cassett with HR Scrn 18x24

Device Class : 2

Duns Number: 793169512

Premarket Exempt : No

Product Code : IXA

Prescription Use : No

Device Count : 1

Ultra-speed - 40889971273723 Catalog Number : 1273721

Device Description : Ultra-speed 100PKT 24x40 film DF55

Device Class :

Duns Number: 793169512

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 100

Ultra-speed - 40889971273747 Catalog Number : 1273747

Device Description : Ultra-speed 100PKT 24x40 film DF56

Device Class :

Duns Number: 793169512

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 100

INSIGHT - 40889971280615 Catalog Number : 1280619

Device Description : INSIGHT 100PKT 22x35 film IP02

Device Class :

Duns Number: 793169512

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 100

DRYVIEW DVB Laser Imaging Film - 40889971286532 Catalog Number : 1286533

Device Description : 125SH 25X30CM (10X12IN) DVB

Device Class :

Duns Number: 793169512

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 125

DIRECTVIEW CR Mammography Cassette with EHR-M Screen - 40889971290386 Catalog Number : 1290386

Device Description : DIRECTVW CR Mammo Cass EHR-M2 Scrn 18x24

Device Class : 2

Duns Number: 793169512

Premarket Exempt : No

Product Code : MUE

Prescription Use : Yes

Device Count : 1

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