KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.

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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) (3) System, X-Ray, Stationary (KPR) (1)

Premarket Exempt

No Yes

Clear

14X17 Cassette for CR Reader - 00817100020476 Catalog Number :

Device Description : CRF-CASSETTE-35X43-R

Device Class : 2

Duns Number: 080269345

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

RF 11X14 Sensor Panel - 00817100020483 Catalog Number :

Device Description : RF 11X14 Sensor Panel -R/-L

Device Class : 2

Duns Number: 080269345

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

Konica Minolta SW (PACS) Opal Rad, 20/20 Opal Rad - 00817100020490 Catalog Number :

Device Description : Opal-RAD is a software device that receives digital images and data from various Opal-RAD is a software device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations.

Device Class : 2

Duns Number: 080269345

Premarket Exempt : No

Product Code : KPR

Prescription Use : Yes

Device Count : 1

RF 11X14 Sensor Panel - 00817100020513 Catalog Number :

Device Description : DR-PANEL-LT1114-L / R

Device Class : 2

Duns Number: 080269345

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

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