FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
6MP COLOR LCD MONITOR, RADIFORCE RX650
K Number: K134002
·
Decision Jan 31, 2014
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
11
Review Days
35
Basic Information
- Device Name
- 6MP COLOR LCD MONITOR, RADIFORCE RX650
- K Number
- K134002
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- EIZO CORPORATION
- Date Received
- December 27, 2013
- Decision Date
- January 31, 2014
- 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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| K151883 | 5MP Monochrome LCD Monitor, RadiForce GX540 | Jul 30, 2015 | Substantially Equivalent |
| K150106 | 2MP Color LCD Monitor, RadiForce RS240 | Apr 3, 2015 | Substantially Equivalent |
| K143261 | 2.3MP Color LCD Monitor, RadiForce MX242W | Nov 21, 2014 | Substantially Equivalent |
| K143098 | 3MP Color LCD monitor, RadiForce RS340 | Nov 18, 2014 | Substantially Equivalent |
| K140702 | 8MP COLOR LCD MONITOR, RADIFORCE RX850 | Apr 4, 2014 | Substantially Equivalent |
| K131090 | 2MP COLOR LCD MONITOR, RADIFORCE MX215 | Jul 3, 2013 | Substantially Equivalent |