FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CTXA HIP; CTXA; QCT PRO CTXA HIP
K Number: K002113
·
Decision Dec 4, 2001
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
144
Applicant Total
3
Review Days
545
Basic Information
- Device Name
- CTXA HIP; CTXA; QCT PRO CTXA HIP
- K Number
- K002113
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1170
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MINDWAYS SOFTWARE, INC.
- Date Received
- June 7, 2000
- Decision Date
- December 4, 2001
- Product Code
- KGI
- 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 |
|---|---|---|---|
| KGI | Densitometer, Bone | FDA class 2 | Radiology |
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