FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HOLOGIC QDR X-RAY BONE DENSITOMETER, MODELS 1000, 2000, 4500, DELPHI, DISCOVERY
K Number: K023398
·
Decision Nov 8, 2002
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
146
Applicant Total
116
Review Days
30
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Basic Information
- Device Name
- HOLOGIC QDR X-RAY BONE DENSITOMETER, MODELS 1000, 2000, 4500, DELPHI, DISCOVERY
- K Number
- K023398
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.1170
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hologic, Inc.
- Date Received
- October 9, 2002
- Decision Date
- November 8, 2002
- 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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