FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EIGEN DSA 2000
K Number: K063846
·
Decision Jan 26, 2007
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
14
Review Days
30
Basic Information
- Device Name
- EIGEN DSA 2000
- K Number
- K063846
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- EIGEN
- Date Received
- December 27, 2006
- Decision Date
- January 26, 2007
- 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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| K903821 | PSC-1 W/OTHER NUMERICAL | Nov 7, 1990 | Substantially Equivalent |
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| K890745 | SC-1000 WITH SUFFIXES (SCAN CONVERTER) | Mar 14, 1989 | Substantially Equivalent |