FDA 510(k)
FDA class 2
Substantially Equivalent
🇧🇪 Belgium
IMPAX VOLUME VIEWING 3.0
K Number: K133135
·
Decision Mar 7, 2014
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
21
Review Days
154
Basic Information
- Device Name
- IMPAX VOLUME VIEWING 3.0
- K Number
- K133135
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- AGFA HEALTHCARE N.V.
- Date Received
- October 4, 2013
- Decision Date
- March 7, 2014
- Product Code
- LLZ
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | FDA class 2 | Radiology |
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|---|---|---|---|
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| K141602 | DX-D IMAGING PACKAGE | Sep 12, 2014 | Substantially Equivalent |
| K141192 | DR 400 | Jun 6, 2014 | Substantially Equivalent |
| K132800 | SKINTELL | Mar 3, 2014 | Substantially Equivalent |
| K131408 | CR 12-X DIGITIZER | Aug 29, 2013 | Substantially Equivalent |
| K122736 | DX-D IMAGING PACKAGE | Mar 11, 2013 | Substantially Equivalent |
| K121095 | DX-D IMAGING PACKAGE | Aug 16, 2012 | Substantially Equivalent |