ORTHOSCAN, INC.

Address:14555 N. 82nd Street,SCOTTSDALE,AZ,85260,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

Image-Intensified Fluoroscopic X-Ray System, Mobile (OXO) (6) System, X-Ray, Fluoroscopic, Image-Intensified (JAA) (5) Solid State X-Ray Imager (Flat Panel/Digital Imager) (MQB) (4)

Premarket Exempt

Clear

OrthoScan HD Mini C-arm - B225100000040 Catalog Number :

Device Description : Image-intensified fluoroscopic x-ray system, mobile

Device Class : 2

Duns Number: 196554021

Premarket Exempt : No

Product Code : OXO, JAA

Prescription Use : Yes

Device Count : 1

OrthoScan Pulse Mini C-arm - B22510000004FD0 Catalog Number :

Device Description : Image-intensified fluoroscopic x-ray system, mobile

Device Class : 2

Duns Number: 196554021

Premarket Exempt : No

Product Code : MQB, OXO

Prescription Use : Yes

Device Count : 1

OrthoScan Mobile DI Mini C-arm - B225100000050 Catalog Number :

Device Description : Image-intensified fluoroscopic x-ray system, mobile

Device Class : 2

Duns Number: 196554021

Premarket Exempt : No

Product Code : OXO, JAA

Prescription Use : Yes

Device Count : 1

TAU Model 1000-0015 Mini C-Arm - B225100000150 Catalog Number :

Device Description : Image-Intensified Fluoroscopic X-Ray System, Mobile

Device Class : 2

Duns Number: 196554021

Premarket Exempt : No

Product Code : OXO, JAA, MQB

Prescription Use : Yes

Device Count : 1

TAU Model 1000-0016 Mini C-Arm - B225100000160 Catalog Number :

Device Description : Image-Intensified Fluoroscopic X-Ray System, Mobile

Device Class : 2

Duns Number: 196554021

Premarket Exempt : No

Product Code : OXO, JAA, MQB

Prescription Use : Yes

Device Count : 1

TAU Model 1000-0017 Mini C-Arm - B225100000170 Catalog Number :

Device Description : Image-Intensified Fluoroscopic X-Ray, Mobile

Device Class : 2

Duns Number: 196554021

Premarket Exempt : No

Product Code : OXO, JAA, MQB

Prescription Use : Yes

Device Count : 1

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