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

Solid state x-ray imager (flat panel/digital imager) (MQB) (7) System, x-ray, mobile (IZL) (2) Full field digital,system,x-ray,mammographic (MUE) (1)

Premarket Exempt

No Yes

Clear

4343R Digital Image Receptor - 60889978607587 Catalog Number : 8607582

Device Description : GOS Scintillator 4343 CM

Device Class : 2

Duns Number: 793169512

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

DIRECTVIEW CR Mammography Cassette with EHR-M Screen - 60889978611614 Catalog Number : 8611618

Device Description : 24X30CM DV REPLCMT PLATE/EHR-M2 SCR

Device Class : 2

Duns Number: 793169512

Premarket Exempt : No

Product Code : MUE

Prescription Use : Yes

Device Count : 1

DRX-Revolution Mobile X-ray System - 60889978612499 Catalog Number : 8612533

Device Description : DRX-REVOLUTION W/TOSHIBA TUBE&CSH GEN

Device Class : 2

Duns Number: 793169512

Premarket Exempt : No

Product Code : IZL

Prescription Use : Yes

Device Count : 1

DRX Plus 2530 C Detector - 60889978615148 Catalog Number : 8615148

Device Description : DRX PLUS 2530C DETECTOR/ RETROFIT

Device Class : 2

Duns Number: 793169512

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

DRX Plus 2530 C Detector - 60889978615179 Catalog Number : 8615171

Device Description : DRX PLUS 2530C DETECTOR/ EVOLUTION

Device Class : 2

Duns Number: 793169512

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

DRX Plus 2530C Detector - 60889978615209 Catalog Number : 8615205

Device Description : DRX PLUS 2530C DETECTOR/ ASCEND

Device Class : 2

Duns Number: 793169512

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

DRX Plus 2530 C Detector - 60889978615247 Catalog Number : 8615247

Device Description : DRX PLUS 2530C DETECTOR/ MOBILE

Device Class : 2

Duns Number: 793169512

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

DRX Plus 2530 C Detector - 60889978618132 Catalog Number : 8618134

Device Description : DRX2530C DETECTOR /MOBILE

Device Class : 2

Duns Number: 793169512

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

DRX Plus 2530 C Detector - 60889978618149 Catalog Number : 8618142

Device Description : DRX2530C DETECTOR /RETROFITS

Device Class : 2

Duns Number: 793169512

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

DRX-Revolution Mobile X-ray System - 60889978618897 Catalog Number : 8618894

Device Description : DRX REVOLUTION MOBILE X-RAY SYSTEM

Device Class : 2

Duns Number: 793169512

Premarket Exempt : No

Product Code : IZL

Prescription Use : Yes

Device Count : 1

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