FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CTXA HIP EXTENDED REFERENCE DATA
K Number: K030330
·
Decision Jun 20, 2003
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
146
Applicant Total
3
Review Days
140
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Basic Information
- Device Name
- CTXA HIP EXTENDED REFERENCE DATA
- K Number
- K030330
- 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
- January 31, 2003
- Decision Date
- June 20, 2003
- 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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