FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
4MP COLOR LCD MONITOR, RADIFORCERX430
K Number: K112466
·
Decision Oct 27, 2011
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
34
Review Days
62
Basic Information
- Device Name
- 4MP COLOR LCD MONITOR, RADIFORCERX430
- K Number
- K112466
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- EIZO NANAO CORPORATION
- Date Received
- August 26, 2011
- Decision Date
- October 27, 2011
- 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 EIZO NANAO CORPORATION
| K Number | Device Name | ||
|---|---|---|---|
| K130336 | 5MP MONOCHROME LCD MONITOR, RADIFORCE GX540 | Mar 28, 2013 | Substantially Equivalent |
| K130070 | 4MP COLOR LCD MONITOR, RADIFORCE RX440 | Feb 8, 2013 | Substantially Equivalent |
| K120451 | 8MP COLOR LCD MONITOR, REDIFORCE RX840 | Aug 3, 2012 | Substantially Equivalent |
| K113562 | 3MP COLOR LCD MONITOR, RADIFORCE RX340 | Jul 16, 2012 | Substantially Equivalent |
| K113240 | 3.7 MP COLOR LCD MONITOR, RADIFORCE MX270W | Apr 20, 2012 | Substantially Equivalent |
| K120407 | 2MP MONOCHROME LCD MONITOR, RADIFORCE GX240 | Apr 19, 2012 | Substantially Equivalent |
| K113784 | 3MP MONOCHROME LCD MONITOR, RADIFORCE GX340 | Mar 2, 2012 | Substantially Equivalent |
| K113844 | RADIFORCE RX240 | Feb 27, 2012 | Substantially Equivalent |
| K113226 | 8MP COLOR LCD MONITOR,RADIFORCE RX840 | Dec 17, 2011 | Substantially Equivalent |
| K112354 | 5MP MONOCHROME LCD MONITOR, RADIFORCE GX530 | Nov 30, 2011 | Substantially Equivalent |