Communications & Power Industries Canada Inc

Address:45 RIVER DRIVE,GEORGETOWN Ontario,CA

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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

Generator, High-Voltage, X-Ray, Diagnostic (IZO) (9) System, X-Ray, Stationary (KPR) (1)

Premarket Exempt

No Yes

Clear

CPI RAD VISION - 00885310000021 Catalog Number :

Device Description : The CPI RAD VISION digital imaging system is a full-featured radiographic imagin The CPI RAD VISION digital imaging system is a full-featured radiographic imaging system that isdesigned to capture digital radiographic X-ray images in hospitals and clinics. Generator controlsfor setting exposure factors and techniques are included along with the image acquisition functions.Images are automatically pre-processed during acquisition, and further image processing may beapplied after the images have been acquired or stored. This allows the image(s) to be enhanced toimprove the visualization of anatomical details.Images may be stored on the built-in hard disk, on optical disc (CD/DVD-R/RW), or on a DICOM 3.0compliant network storage device.This is a non-invasive device, designed to image the major systems of the body: Skull, neck, chest,abdomen, pelvis, and extremities. It is not intended for mammographic, fluoroscopic, and / orangiographic applications.The CPI RAD VISION digital imaging system is intended for use with CPI CMP 200 DR or Indico100 X-ray generators.

Device Class : 2

Duns Number: 203144092

Premarket Exempt : No

Product Code : KPR

Prescription Use : Yes

Device Count : 1

CMP 200 DR - 00885310000038 Catalog Number : NA

Device Description : Generator, High-Voltage, X-Ray, Diagnostic, CMP200, RAD, 50kW, 400V

Device Class : 1

Duns Number: 202887311

Premarket Exempt : Yes

Product Code : IZO

Prescription Use : No

Device Count : 1

CMP200 DR - 00885310000045 Catalog Number :

Device Description : Generator, High-Voltage, X-Ray, Diagnostic, CMP200, RAD, 50kW, 480V

Device Class : 1

Duns Number: 202887311

Premarket Exempt : Yes

Product Code : IZO

Prescription Use : No

Device Count : 1

CMP 200 DR - 00885310000052 Catalog Number :

Device Description : Generator, High-Voltage, X-Ray, Diagnostic, CMP200, RAD, 50kW, 208/230V,3PH.

Device Class : 1

Duns Number: 202887311

Premarket Exempt : Yes

Product Code : IZO

Prescription Use : No

Device Count : 1

CMP 200 DR - 00885310000069 Catalog Number :

Device Description : Generator, High-Voltage, X-Ray, Diagnostic ,CMP200, RAD, 65kW, 400V

Device Class : 1

Duns Number: 202887311

Premarket Exempt : Yes

Product Code : IZO

Prescription Use : No

Device Count : 1

CMP 200 DR - 00885310000076 Catalog Number :

Device Description : Generator, High-Voltage, X-Ray, Diagnostic ,CMP200, RAD, 65kW, 480V

Device Class : 1

Duns Number: 202887311

Premarket Exempt : Yes

Product Code : IZO

Prescription Use : No

Device Count : 1

CMP 200 DR - 00885310000083 Catalog Number :

Device Description : Generator, High-Voltage, X-Ray, Diagnostic, CMP200, RAD, 80kW, 400V

Device Class : 1

Duns Number: 202887311

Premarket Exempt : Yes

Product Code : IZO

Prescription Use : No

Device Count : 1

CMP 200 DR - 00885310000090 Catalog Number :

Device Description : Generator, High-Voltage, X-Ray, Diagnostic, CMP200, RAD, 80kW, 480V

Device Class : 1

Duns Number: 202887311

Premarket Exempt : Yes

Product Code : IZO

Prescription Use : No

Device Count : 1

CMP 200 DR - 00885310000106 Catalog Number :

Device Description : Generator, High-Voltage, X-Ray, Diagnostic ,CMP200, RAD, 40kW, 400V

Device Class : 1

Duns Number: 202887311

Premarket Exempt : Yes

Product Code : IZO

Prescription Use : No

Device Count : 1

CMP 200 DR - 00885310000113 Catalog Number :

Device Description : Generator, High-Voltage, X-Ray, Diagnostic ,CMP200, RAD, 40kW, 480V

Device Class : 1

Duns Number: 202887311

Premarket Exempt : Yes

Product Code : IZO

Prescription Use : No

Device Count : 1

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