FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
21.3 (54 CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR, MODEL MS3112 (MDL2128A)
K Number: K090947
·
Decision Aug 16, 2010
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
5
Review Days
500
Basic Information
- Device Name
- 21.3 (54 CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR, MODEL MS3112 (MDL2128A)
- K Number
- K090947
- 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
- April 3, 2009
- Decision Date
- August 16, 2010
- 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 TOTOKU ELECTRIC CO., LTD.
| K Number | Device Name | ||
|---|---|---|---|
| K113443 | 21.3 INCH (54 CM) MONOCHROME LCD MONITOR MS23I2 (ML21023) | Dec 23, 2011 | Substantially Equivalent |
| K081055 | 21.3 (54CM) 2M COLOR LCD MONITOR CCL254I2 (CDL2125A) | Jun 4, 2008 | Substantially Equivalent |
| K081056 | 21.3 (54CM) 3M COLOR LCD MONITOR CCL354I2 (CDL2126A) | Jun 4, 2008 | Substantially Equivalent |
| K051403 | 19-INCH (48CM) COLOR LCD MONITOR CDL1904A | Jul 14, 2005 | Substantially Equivalent |