FDA 510(k)
FDA class 2
Substantially Equivalent
🇧🇪 Belgium
COLOR CORONIS 2MP-21 AND MFCD 2321
K Number: K052352
·
Decision Sep 30, 2005
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
17
Review Days
32
Basic Information
- Device Name
- COLOR CORONIS 2MP-21 AND MFCD 2321
- K Number
- K052352
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BARCOVIEW
- Date Received
- August 29, 2005
- Decision Date
- September 30, 2005
- 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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Other Clearances by BARCOVIEW
| K Number | Device Name | ||
|---|---|---|---|
| K062621 | NIO 5MP-21 AND MDNG-5121 CB | Mar 19, 2007 | Substantially Equivalent |
| K062905 | NIO FUSION 4MP; MDNC 4130 | Dec 29, 2006 | Substantially Equivalent |
| K062131 | NIO 5MP-M-21 (NIO 5MP MAMMO); MDNG-5121 BB | Nov 17, 2006 | Substantially Equivalent |
| K061928 | CORONIS COLOR 2MP AND MDCC 2121 | Sep 5, 2006 | Substantially Equivalent |
| K061927 | CORONIS COLOR 3MP AND MDCC 3120-DL | Sep 5, 2006 | Substantially Equivalent |
| K061924 | CORONIS 3MP AND MDCG 3120-CB | Sep 5, 2006 | Substantially Equivalent |
| K061926 | CORONIS 2MP AND MDCG 2121 - CB | Aug 18, 2006 | Substantially Equivalent |
| K052958 | COLOR NIO 2MP, E-2320 C | Nov 16, 2005 | Substantially Equivalent |
| K052529 | E-2320 PA S | Sep 30, 2005 | Substantially Equivalent |
| K052478 | MFCD 1219, MFCD 1219 TS | Sep 28, 2005 | Substantially Equivalent |