FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COMPUTED RADIOGRAPHY SCANNER
K Number: K133120
·
Decision Jan 15, 2014
Classifications
1
FEI Numbers
126
Registration Numbers
126
Same Product Code
422
Applicant Total
5
Review Days
107
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Basic Information
- Device Name
- COMPUTED RADIOGRAPHY SCANNER
- K Number
- K133120
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.1680
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- 3Disc Americas
- Date Received
- September 30, 2013
- Decision Date
- January 15, 2014
- Product Code
- MQB
- 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 |
|---|---|---|---|
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | FDA class 2 | Radiology |
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Other Clearances by 3Disc Americas
| K Number | Device Name | ||
|---|---|---|---|
| K151687 | QuantorView | Aug 3, 2015 | Substantially Equivalent |
| K133106 | COMPUTED RADIOGRAPHY SCANNER | Jan 15, 2014 | Substantially Equivalent |
| K131442 | FIRECR DENTALIMAGING SYSTEM | Sep 6, 2013 | Substantially Equivalent |
| K102619 | COMPUTED RADDIOGRAPHY SCANNER | May 13, 2011 | Substantially Equivalent |