FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOGRAPH 6 TRUEPOINT, MODEL BIOGRAPH 6 - P/N 10238197
K Number: K071068
·
Decision May 14, 2007
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
459
Applicant Total
519
Review Days
28
Basic Information
- Device Name
- BIOGRAPH 6 TRUEPOINT, MODEL BIOGRAPH 6 - P/N 10238197
- K Number
- K071068
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.1200
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SIEMENS MEDICAL SOLUTIONS USA, INC.
- Date Received
- April 16, 2007
- Decision Date
- May 14, 2007
- Product Code
- KPS
- 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 |
|---|---|---|---|
| KPS | System, Tomography, Computed, Emission | FDA class 2 | Radiology |
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