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

System, X-Ray, Stationary (KPR) (5) Solid State X-Ray Imager (Flat Panel/Digital Imager) (MQB) (3) System, Image Processing, Radiological (LLZ) (2) System, X-Ray, Mobile (IZL) (1)

Premarket Exempt

No Yes

Clear

Portable X-Ray System - 00817100020124 Catalog Number :

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

Device Class : 2

Duns Number: 080269345

Premarket Exempt : No

Product Code : IZL

Prescription Use : Yes

Device Count : 1

2020 Imaging Podiatry System - 00817100020131 Catalog Number : BD715

Device Description : 20/20 BiDirectional PDR X-ray Machine.

Device Class : 2

Duns Number: 080269345

Premarket Exempt : Yes

Product Code : KPR

Prescription Use : Yes

Device Count : 1

2020 Imaging Podiatry System HF - 00817100020148 Catalog Number : PXS-710

Device Description : X-Ray System, Podiatry DR Ready (70kVp,10mA).

Device Class : 2

Duns Number: 080269345

Premarket Exempt : No

Product Code : KPR, MQB

Prescription Use : Yes

Device Count : 1

2020i Imaging Hand System - 00817100020155 Catalog Number : HDR

Device Description : Dedicated Hand X-Ray system

Device Class : 2

Duns Number: 080269345

Premarket Exempt : Yes

Product Code : KPR

Prescription Use : Yes

Device Count : 1

2020i Straight Arm - 00817100020162 Catalog Number : 2020SA

Device Description : 2020i 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

Konica Minolta SW (Acquire) Ultra - 00817100020179 Catalog Number :

Device Description : ViZion Ultra is intended for digital image capture use in general radiographic e ViZion Ultra is intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. ViZion Ultra allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities.

Device Class : 2

Duns Number: 080269345

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

Konica Minolta SW (Acquire) Opal, 20/20 Opal (Acquire) Vizion - 00817100020186 Catalog Number :

Device Description : Software, Opal Acquire Image Acquisition Software.

Device Class : 2

Duns Number: 080269345

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

Konica Minolta SW (PACS) Exa - 00817100020193 Catalog Number :

Device Description : EXA is a software device that receives digital images and data from various sour EXA 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.Lossy compressed mammographic images are not intended for diagnostic review.

Device Class : 2

Duns Number: 080269345

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

Konica Minolta SW (PACS) Opal Rad, 20/20 Opal Rad - 00817100020209 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

17X17 CsI Fixed Flat Panel Detector - 00817100020216 Catalog Number :

Device Description : IR 17X17 CsI Fixed Flat Panel Detector (-R or -L)

Device Class : 2

Duns Number: 080269345

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

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