FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
5MP Monochrome LCD Monitor, RadiForce GX550, GX550-AR
K Number: K162497
·
Decision Sep 19, 2016
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
130
Applicant Total
11
Review Days
12
Basic Information
- Device Name
- 5MP Monochrome LCD Monitor, RadiForce GX550, GX550-AR
- K Number
- K162497
- 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
- September 7, 2016
- Decision Date
- September 19, 2016
- Product Code
- PGY
- 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 |
|---|---|---|---|
| PGY | Display, Diagnostic Radiology | FDA class 2 | Radiology |
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Other Clearances by EIZO CORPORATION
| K Number | Device Name | ||
|---|---|---|---|
| K163335 | 6MP Color LCD Monitor, RadiForce RX660, RX660-AR | Dec 15, 2016 | Substantially Equivalent |
| K153354 | 3MP Color LCD Monitor, RadiForce RX350 | Jan 12, 2016 | Substantially Equivalent |
| K152713 | 8MP Color LCD Monitor, RadiForce RX850, RX850-AR | Nov 20, 2015 | Substantially Equivalent |
| 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 |
| K134002 | 6MP COLOR LCD MONITOR, RADIFORCE RX650 | Jan 31, 2014 | Substantially Equivalent |
| K131090 | 2MP COLOR LCD MONITOR, RADIFORCE MX215 | Jul 3, 2013 | Substantially Equivalent |