FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SYNGO DUAL ENERGY WITH EXTENDED FUNCTIONALLY
K Number: K073003
·
Decision Feb 7, 2008
Classifications
1
FEI Numbers
164
Registration Numbers
164
Same Product Code
795
Applicant Total
19
Review Days
106
Basic Information
- Device Name
- SYNGO DUAL ENERGY WITH EXTENDED FUNCTIONALLY
- K Number
- K073003
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.1750
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SIEMENS MEDICAL SOLUTIONS, INC.
- Date Received
- October 24, 2007
- Decision Date
- February 7, 2008
- Product Code
- JAK
- 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 |
|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | FDA class 2 | Radiology |
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