FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
DDRCRUZE (DIGITAL MOBILE DIAGNOSTIC X-RAY SYSTEM)
K Number: K131314
·
Decision Jun 25, 2013
Classifications
1
FEI Numbers
126
Registration Numbers
126
Same Product Code
422
Applicant Total
4
Review Days
49
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Basic Information
- Device Name
- DDRCRUZE (DIGITAL MOBILE DIAGNOSTIC X-RAY SYSTEM)
- K Number
- K131314
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1680
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Swissray Medical AG
- Date Received
- May 7, 2013
- Decision Date
- June 25, 2013
- Product Code
- MQB
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- Y
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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