FDA 510(k)
FDA class 2
Substantially Equivalent
🇧🇪 Belgium
NIO COLOR 3MP AND MDNC-3121
K Number: K090732
·
Decision Apr 20, 2009
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
36
Review Days
32
Basic Information
- Device Name
- NIO COLOR 3MP AND MDNC-3121
- K Number
- K090732
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- BARCO NV
- Date Received
- March 19, 2009
- Decision Date
- April 20, 2009
- Product Code
- LLZ
- 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 |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LLZ), ordered by most recent decision date.
CustomSurg OrthoPlanner
FDA 510(k)
FDA Class 2
·Radiology
uOmniscan
FDA 510(k)
FDA Class 2
·Radiology
Mosaic (V1.0.1)
FDA 510(k)
FDA Class 2
·Radiology
UroNav 4
FDA 510(k)
FDA Class 2
·Radiology
TechLive
FDA 510(k)
FDA Class 2
·Radiology
SMARTDent
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by BARCO NV
| K Number | Device Name | ||
|---|---|---|---|
| K143157 | Coronis Fusion 4MP LED | Nov 12, 2014 | Substantially Equivalent |
| K133984 | CORONIS 5MP | Mar 28, 2014 | Substantially Equivalent |
| K131295 | NIO COLOR 3MP LED | May 29, 2013 | Substantially Equivalent |
| K122167 | NEXXIS OR | Apr 22, 2013 | Substantially Equivalent |
| K121788 | NIO 5MP | Jul 23, 2012 | Substantially Equivalent |
| K111990 | CORONIS 5MP | Oct 17, 2011 | Substantially Equivalent |
| K111989 | CORONIS FUSION 4MP DL | Sep 22, 2011 | Substantially Equivalent |
| K111991 | NIO COLOR 2MP | Aug 11, 2011 | Substantially Equivalent |
| K103792 | BARCO MAMMO TOMOSYNTHESIS | Mar 4, 2011 | Substantially Equivalent |
| K093197 | CORONIS FUSION 10MP, MODEL MDCG-10130 | Jun 23, 2010 | Substantially Equivalent |