FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PLANMED SOPHIE NUANCE CLASSIC
K Number: K042671
·
Decision Nov 19, 2004
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
175
Applicant Total
20
Review Days
51
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Basic Information
- Device Name
- PLANMED SOPHIE NUANCE CLASSIC
- K Number
- K042671
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1710
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Planmed OY
- Date Received
- September 29, 2004
- Decision Date
- November 19, 2004
- 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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| K121418 | PLANMED VERITY | Feb 1, 2013 | Substantially Equivalent |
| K121963 | PLANMED NUANCE DIGIGUIDE | Nov 21, 2012 | Substantially Equivalent |
| K021945 | PLANMED SOPHIE & SOPHIE CLASSIC (WITH DIGISPOT AND CYTOGUIDE) | Feb 21, 2003 | Substantially Equivalent |