FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BODY COMPOSITION SOFTWARE OPTION FOR QDR X-RAY BONE DENSITOMETERS
K Number: K961787
·
Decision Jun 13, 1997
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
144
Applicant Total
72
Review Days
400
Basic Information
- Device Name
- BODY COMPOSITION SOFTWARE OPTION FOR QDR X-RAY BONE DENSITOMETERS
- K Number
- K961787
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1170
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- HOLOGIC, INC.
- Date Received
- May 9, 1996
- Decision Date
- June 13, 1997
- 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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