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

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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) (8) System, X-Ray, Fluoroscopic, Image-Intensified (JAA) (1) System, X-Ray, Mobile (IZL) (1)

Premarket Exempt

No Yes

Clear

Straight Arm System - 00817100020018 Catalog Number :

Device Description : Universal Radiographic Straight Arm system variable focal distance left loading Only.

Device Class : 2

Duns Number: 080269345

Premarket Exempt : No

Product Code : KPR

Prescription Use : Yes

Device Count : 1

U-Arm System Basic - 00817100020025 Catalog Number :

Device Description : Universal U-arm system - Motorized.

Device Class : 2

Duns Number: 080269345

Premarket Exempt : No

Product Code : KPR

Prescription Use : Yes

Device Count : 1

U-Arm System - 00817100020032 Catalog Number :

Device Description : Universal U-arm system - With Motorized Auto Positioning and Touchscreen control

Device Class : 2

Duns Number: 080269345

Premarket Exempt : No

Product Code : KPR

Prescription Use : Yes

Device Count : 1

Advanced Universal U-Arm Stand 3000 - 00817100020049 Catalog Number :

Device Description : Advanced Universal U-arm Stand 3000 - 8' Motorized Auto Positioning and Touchs Advanced Universal U-arm Stand 3000 - 8' Motorized Auto Positioning and Touchscreen control

Device Class : 2

Duns Number: 080269345

Premarket Exempt : No

Product Code : KPR

Prescription Use : Yes

Device Count : 1

Advanced Universal U-Arm Stand 4000 - 00817100020056 Catalog Number :

Device Description : Advanced Universal U-arm Stand 4000 - Motorized Auto Positioning and Touchscreen control

Device Class : 2

Duns Number: 080269345

Premarket Exempt : No

Product Code : KPR

Prescription Use : Yes

Device Count : 1

Millenium Floor Mounted Tube Stand - 00817100020063 Catalog Number :

Device Description : Floor-Mounted Tubestand longitudinal tube travel 2m. with advanced control with Floor-Mounted Tubestand longitudinal tube travel 2m. with advanced control with Digital SID

Device Class : 2

Duns Number: 080269345

Premarket Exempt : No

Product Code : KPR

Prescription Use : Yes

Device Count : 1

Overhead Tube Crane Ceiling Suspension - 00817100020070 Catalog Number :

Device Description : Manual ceiling suspension tube stand ONLY

Device Class : 2

Duns Number: 080269345

Premarket Exempt : No

Product Code : KPR

Prescription Use : Yes

Device Count : 1

Overhead Tube Crane - 00817100020094 Catalog Number :

Device Description : NOVA CSAP Ceiling suspension tube stand Motorized with Auto positioning and touc NOVA CSAP Ceiling suspension tube stand Motorized with Auto positioning and touch screen panel (to work with auto position table and wall stand versions).

Device Class : 2

Duns Number: 080269345

Premarket Exempt : No

Product Code : KPR

Prescription Use : Yes

Device Count : 1

Dynamic DR Room - 00817100020100 Catalog Number :

Device Description : Platinum Radiographic / Fluoroscopic system 90/90 DRF43 FL with generator and X-Ray tube.

Device Class : 2

Duns Number: 080269345

Premarket Exempt : No

Product Code : JAA

Prescription Use : Yes

Device Count : 1

Portable X-Ray System - 00817100020117 Catalog Number :

Device Description : SR-130 + DR Portable X-Ray System (100kV/30mA).

Device Class : 2

Duns Number: 080269345

Premarket Exempt : No

Product Code : IZL

Prescription Use : Yes

Device Count : 1

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