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) (2) Film, radiographic (IWZ) (2) System, digital image communications, radiological (LMD) (1)

Premarket Exempt

No Yes

Clear

Vue RIS - 60889978671366 Catalog Number : 8671364

Device Description : RIS SOFTWARE < 25K EXAMS / YEAR

Device Class : 1

Duns Number: 793169512

Premarket Exempt : Yes

Product Code : LMD

Prescription Use : No

Device Count : 1

INSIGHT VHC Thoracic Screens - 60889978678921 Catalog Number : 8678922

Device Description : PR 35X35CM INSGHT VHC SCREEN C1

Device Class : 1

Duns Number: 793169512

Premarket Exempt : Yes

Product Code : EAM

Prescription Use : No

Device Count : 1

MIN-R 2190 Screen - 60889978686957 Catalog Number : 8686958

Device Description : 24X30CM MIN-R 2190 SCR W/O FM F/OEM

Device Class : 1

Duns Number: 793169512

Premarket Exempt : Yes

Product Code : EAM

Prescription Use : No

Device Count : 1

READYMATIC Fixer and Replenisher - 60889978712878 Catalog Number : 8712879

Device Description : READYMATIC Fixer and Repl - 4x1GL

Device Class : 1

Duns Number: 793169512

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 1

CR Cassettes for Vita Systems - 60889978719662 Catalog Number : 8719668

Device Description : 35X35CM CR CASSETTE GP PLUS

Device Class : 2

Duns Number: 793169512

Premarket Exempt : No

Product Code : IXA

Prescription Use : Yes

Device Count : 1

MIN-R 2000 Screen - 60889978722358 Catalog Number : 8722357

Device Description : SGL 24X30CM MINR2000 S W/O FM F/OEM

Device Class : 1

Duns Number: 793169512

Premarket Exempt : Yes

Product Code : EAM

Prescription Use : No

Device Count : 1

DIRECTVIEW CR Long-Length Cassette with PQ Screen - 60889978754144 Catalog Number : 8754145

Device Description : CR LONG LENGTH PORTABLE CASS W/PQ

Device Class : 2

Duns Number: 793169512

Premarket Exempt : No

Product Code : IXA

Prescription Use : No

Device Count : 1

Imaging Plate - 60889978770717 Catalog Number : 8770711

Device Description : CR IMAGING PLATE PAN V2 5X12IN

Device Class : 1

Duns Number: 793169512

Premarket Exempt : Yes

Product Code : EAM

Prescription Use : Yes

Device Count : 1

READYMATIC Developer and Replenisher - 60889978777532 Catalog Number : 8777534

Device Description : READYMATIC Developer and Repl - 4x1GL

Device Class : 1

Duns Number: 793169512

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 1

EV Screens - 60889978793457 Catalog Number : 8793457

Device Description : EV SCR 1PR 15x30cm NF

Device Class : 1

Duns Number: 793169512

Premarket Exempt : Yes

Product Code : EAM

Prescription Use : No

Device Count : 1

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