FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PLANMED SOPHIE, PLANMED SOPHIE CLASSIC
K Number: K010116
·
Decision Mar 15, 2001
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
175
Applicant Total
20
Review Days
58
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Basic Information
- Device Name
- PLANMED SOPHIE, PLANMED SOPHIE CLASSIC
- K Number
- K010116
- 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
- January 16, 2001
- Decision Date
- March 15, 2001
- 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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Other Clearances by Planmed OY
| K Number | Device Name | ||
|---|---|---|---|
| K250318 | Planmed XFI | Sep 26, 2025 | Substantially Equivalent |
| K211720 | Planmed Clarity 2D, Planmed Clarify S | Jul 18, 2022 | Substantially Equivalent |
| K213278 | Planmed Verity | Apr 28, 2022 | Substantially Equivalent |
| K192317 | Planmed Clarity 2D and Clarity S | Oct 23, 2020 | Substantially Equivalent |
| K180918 | Planmed Verity | Nov 30, 2018 | Substantially Equivalent |
| K163328 | Planmed Clarity | Dec 28, 2017 | Substantially Equivalent |
| K143435 | Planmed Verity | May 14, 2015 | Substantially Equivalent |
| K121418 | PLANMED VERITY | Feb 1, 2013 | Substantially Equivalent |
| K121963 | PLANMED NUANCE DIGIGUIDE | Nov 21, 2012 | Substantially Equivalent |
| K042671 | PLANMED SOPHIE NUANCE CLASSIC | Nov 19, 2004 | Substantially Equivalent |