FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
21.3-INCH (54CM) MONOCHROME LCD MONITOR MS21I2 (MDL2127A)
K Number: K081945
·
Decision Sep 12, 2008
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
35
Review Days
66
Basic Information
- Device Name
- 21.3-INCH (54CM) MONOCHROME LCD MONITOR MS21I2 (MDL2127A)
- K Number
- K081945
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- TOTOKU ELECTRIC CO., LTD
- Date Received
- July 8, 2008
- Decision Date
- September 12, 2008
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LLZ), ordered by most recent decision date.
CustomSurg OrthoPlanner
FDA 510(k)
FDA Class 2
·Radiology
uOmniscan
FDA 510(k)
FDA Class 2
·Radiology
Mosaic (V1.0.1)
FDA 510(k)
FDA Class 2
·Radiology
UroNav 4
FDA 510(k)
FDA Class 2
·Radiology
TechLive
FDA 510(k)
FDA Class 2
·Radiology
SMARTDent
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by TOTOKU ELECTRIC CO., LTD
| K Number | Device Name | ||
|---|---|---|---|
| K113136 | 21.3INCH (54CM)COLOR LCD MONITOR CCL256I2(CL21256) | Dec 20, 2011 | Substantially Equivalent |
| K112145 | MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS33I2 | Nov 7, 2011 | Substantially Equivalent |
| K112604 | 21.3 INCH (54 CM) COLOR LCD MONITOR CCL356I2 (CL21356) | Oct 27, 2011 | Substantially Equivalent |
| K111496 | 21.3 INCH (54CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR | Sep 26, 2011 | Substantially Equivalent |
| K092728 | 20.1 INCH (51 CM) COLOR LCD MONITOR CCL208 (CDL2013A) | Nov 19, 2010 | Substantially Equivalent |
| K080951 | 19-INCH (48CM) 1.3M COLOR LCD MONITOR CDL1909A | May 29, 2008 | Substantially Equivalent |
| K080952 | 15-INCH (38 CM) COLOR LCD MONITOR CDL1576A | May 29, 2008 | Substantially Equivalent |
| K071794 | 15M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MDL2123A (MS51I2) | Feb 11, 2008 | Substantially Equivalent |
| K072065 | 20.8-INCH (53CM) COLOR LCD MONITOR CDL2119A (CCL352I2) | Aug 14, 2007 | Substantially Equivalent |
| K072066 | 1.3M MONOCHROME LCD MONITOR MDL1908A | Aug 14, 2007 | Substantially Equivalent |