FDA 510(k)
FDA class 2
Substantially Equivalent
🇧🇪 Belgium
NIO COLOR 3MP LED
K Number: K131295
·
Decision May 29, 2013
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
36
Review Days
23
Basic Information
- Device Name
- NIO COLOR 3MP LED
- K Number
- K131295
- 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
- May 6, 2013
- Decision Date
- May 29, 2013
- 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 |
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|---|---|---|---|
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| K122167 | NEXXIS OR | Apr 22, 2013 | Substantially Equivalent |
| K121788 | NIO 5MP | Jul 23, 2012 | Substantially Equivalent |
| K111990 | CORONIS 5MP | Oct 17, 2011 | Substantially Equivalent |
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| 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 |
| K091274 | CORONIS 5MP HD, MODEL MDMG 5121 | Jul 14, 2009 | Substantially Equivalent |