CPI RAD Vision

The CPI RAD VISION digital imaging system is a full-featured radiographic imaging system that is designed to capture digital radiographic X-ray images in hospitals and clinics. Generator…

Registry build 21.09.26

The CPI RAD VISION digital imaging system is a full-featured radiographic imaging system that is designed to capture digital radiographic X-ray images in hospitals and clinics. Generator controls for 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 be applied after the images have been acquired or stored. This allows the image(s) to be enhanced to improve 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 3.0 compliant 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 / or angiographic applications. The CPI RAD VISION digital imaging system is intended for use with CPI CMP 200 DR or Indico 100 X-ray generators.

7manufacturers in China registered for this device type
1catalogue number
1510(k) clearance

Who Else Makes It

Concentrated in Shanghai (3), Beijing (2), Jiangsu (1).

Chinese manufacturers registered for FDA product code KPR
Manufacturer City Province Registered as Device types
GE Hangwei Medical Systems Co., Ltd. Beijing Beijing Specification developer 22
GE Healthcare (China) Co., Ltd. Beijing Beijing Specification developer 22
Shanghai United Imaging Healthcare Co., Ltd. Shanghai Shanghai Manufacturer 12
Siemens Shanghai, Medical Equipment Ltd. Shanghai Shanghai Contract manufacturer 10
Carestream Health, Inc., Global R&D Center Shanghai Shanghai Specification developer 8
Philips Healthcare (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 5
Orich Medical Equipment (Tianjin) Co., Ltd. Tianjin Tianjin Manufacturer 5

Record

Regulatory record for CPI RAD Vision
Listed by Communications & Power Industries Canada, Inc., Canada
FDA product code KPR
Device type System, X-Ray, Stationary
Device class Class 2
Regulation 21 CFR 892.1680
Establishment Manufacturer
Record published 2017-02-06
Record revised 2018-03-29 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only

Catalogue Numbers

Catalogue numbers for CPI RAD Vision
Catalogue number Size Status
VZW2944M9 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Drgem Drgem Corporation 171
Q-RAD System Carestream Health, Inc. 159
DRX – Ascend System Carestream Health, Inc. 121
FDR Clinica Drgem Corporation 41
RADspeed Pro Shimadzu Corp. 31
FDR Visionary Suite Shimadzu Corp. 17
Exsys DEXi Drtech Corporation 15
Del Medical, Inc. DEL Medical, Inc. 15
GXR-Es,ecs Diagnostic X-ray System Drgem Corporation 14
X-CEL X-RAY Corporation Arquilla, Inc. 14
DRX-Evolution Plus System Carestream Health, Inc. 12
Carestream DRX-Evolution Carestream Health, Inc. 10

Showing 12 of 138. All products under System, X-Ray, Stationary

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K122726 2013-02-15

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer