FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOPSY-DIGIT
K Number: K990192
·
Decision Mar 12, 1999
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
175
Applicant Total
4
Review Days
50
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Basic Information
- Device Name
- BIOPSY-DIGIT
- K Number
- K990192
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1710
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sitco, Inc.
- Date Received
- January 21, 1999
- Decision Date
- March 12, 1999
- Product Code
- IZH
- 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 |
|---|---|---|---|
| IZH | System, X-Ray, Mammographic | FDA class 2 | Radiology |
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