FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PLANMED SOPHIE & SOPHIE CLASSIC (WITH DIGISPOT AND CYTOGUIDE)
K Number: K021945
·
Decision Feb 21, 2003
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
175
Applicant Total
20
Review Days
253
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Basic Information
- Device Name
- PLANMED SOPHIE & SOPHIE CLASSIC (WITH DIGISPOT AND CYTOGUIDE)
- K Number
- K021945
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1710
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Planmed OY
- Date Received
- June 13, 2002
- Decision Date
- February 21, 2003
- 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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