FDA 510(k)
FDA class 2
Substantially Equivalent
🇧🇪 Belgium
IMPAX VOLUME VIEWING
K Number: K111638
·
Decision Jun 24, 2011
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
21
Review Days
11
Basic Information
- Device Name
- IMPAX VOLUME VIEWING
- K Number
- K111638
- 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
- June 13, 2011
- Decision Date
- June 24, 2011
- 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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Other Clearances by AGFA HEALTHCARE N.V.
| K Number | Device Name | ||
|---|---|---|---|
| K161061 | IMPAX Volume Viewing 4.0 | Jun 22, 2016 | Substantially Equivalent |
| K152639 | DR 600 | Dec 11, 2015 | Substantially Equivalent |
| K142316 | IMPAX Agility | Jan 6, 2015 | Substantially Equivalent |
| K142184 | DX-D IMAGING PACKAGE | Oct 16, 2014 | Substantially Equivalent |
| K141602 | DX-D IMAGING PACKAGE | Sep 12, 2014 | Substantially Equivalent |
| K141192 | DR 400 | Jun 6, 2014 | Substantially Equivalent |
| K133135 | IMPAX VOLUME VIEWING 3.0 | Mar 7, 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 |