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

System, x-ray, stationary (KPR) (5) Solid state x-ray imager (flat panel/digital imager) (MQB) (4) Cassette, radiographic film (IXA) (1)

Premarket Exempt

No Yes

Clear

DIRECTVIEW CR Cassette with PQ Screen - 60889978619108 Catalog Number : 8619108

Device Description : 10SC 35X43CM DIRECTVIEW PQ SCR

Device Class :

Duns Number: 793169512

Premarket Exempt : No

Product Code : IXA

Prescription Use : No

Device Count : 10

DRX-Transportable System - 60889978619986 Catalog Number : 8619983

Device Description : DRX-TRANSPORTABLE SYSTEM/LITE

Device Class : 2

Duns Number: 793169512

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

NONE - 60889978621613 Catalog Number : 8621617

Device Description : X-RAY SYSTEM CONSOLE PDU 3P 380-480 C/F

Device Class : 2

Duns Number: 793169512

Premarket Exempt : No

Product Code : KPR

Prescription Use : No

Device Count : 1

Value Systems - 60889978621651 Catalog Number : 8621658

Device Description : GENERATOR GRP C 50KW 3P 380-480 VAC

Device Class : 2

Duns Number: 793169512

Premarket Exempt : No

Product Code : KPR

Prescription Use : No

Device Count : 1

Value Systems - 60889978621668 Catalog Number : 8621666

Device Description : GENERATOR GRP D 50KW 3P 208-240 VAC

Device Class : 2

Duns Number: 793169512

Premarket Exempt : No

Product Code : KPR

Prescription Use : No

Device Count : 1

NONE - 60889978622351 Catalog Number : 8622359

Device Description : X-RAY SYSTEM CONSOLE PDU 3P 208-240 C/F

Device Class : 2

Duns Number: 793169512

Premarket Exempt : No

Product Code : KPR

Prescription Use : No

Device Count : 1

Focus Detector - 60889978622382 Catalog Number : 8622383

Device Description : FOCUS 35C DETECTOR FOR ROOM SYSTEMS/WP

Device Class : 2

Duns Number: 793169512

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

CARESTREAM DRX-1 System - 60889978622795 Catalog Number : 8622797

Device Description : CARESTREAM DRX-1 SYSTEM

Device Class : 2

Duns Number: 793169512

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

Lux Detector - 60889978623280 Catalog Number : 8623282

Device Description : LUX 35 DETECTOR /RETROFIT

Device Class : 2

Duns Number: 793169512

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

DRX-Compass X-ray System - 60889978624188 Catalog Number : 8624181

Device Description : X-RAY SYSTEM CONSOLE PDU 3 P 380-480 C/F

Device Class : 2

Duns Number: 793169512

Premarket Exempt : No

Product Code : KPR

Prescription Use : Yes

Device Count : 1

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