FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
CPI RAD VISION, MODEL VZW2944XX-YY
K Number: K083224
·
Decision Mar 24, 2009
Classifications
1
FEI Numbers
126
Registration Numbers
126
Same Product Code
422
Applicant Total
3
Review Days
141
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Basic Information
- Device Name
- CPI RAD VISION, MODEL VZW2944XX-YY
- K Number
- K083224
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1680
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Communications & Power Industries Canada, Inc.
- Date Received
- November 3, 2008
- Decision Date
- March 24, 2009
- Product Code
- MQB
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | FDA class 2 | Radiology |
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