FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PERFORMA STEREO
K Number: K023864
·
Decision Jan 9, 2003
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
175
Applicant Total
3
Review Days
50
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Basic Information
- Device Name
- PERFORMA STEREO
- K Number
- K023864
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1710
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Instrumentarium Corp. Imaging Division
- Date Received
- November 20, 2002
- Decision Date
- January 9, 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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