FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇮 Finland
Planmeca Romexis
K Number: K200572
·
Decision Dec 2, 2020
Classifications
1
FEI Numbers
599
Registration Numbers
599
Same Product Code
2271
Applicant Total
28
Review Days
272
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Basic Information
- Device Name
- Planmeca Romexis
- K Number
- K200572
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Planmeca Oy
- Date Received
- March 5, 2020
- Decision Date
- December 2, 2020
- Product Code
- LLZ
- 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 |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | FDA class 2 | Radiology |
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| K Number | Device Name | ||
|---|---|---|---|
| K230985 | Planmeca Viso | Dec 28, 2023 | Substantially Equivalent |
| K181576 | Planmeca Viso | Sep 13, 2018 | Substantially Equivalent |
| K171385 | Planmeca Romexis | Nov 14, 2017 | Substantially Equivalent |
| K160506 | Planmeca ProMax 3D Max, Planmeca Maximity | May 20, 2016 | Substantially Equivalent |
| K140713 | PLANMECA ROMEXIS | Jun 16, 2014 | Substantially Equivalent |
| K103689 | PLANMECA PROMAX 3D MID | Mar 17, 2011 | Substantially Equivalent |
| K093590 | PLANMECA PROMAX 3D MAX | May 12, 2010 | Substantially Equivalent |
| K091197 | PLANMECA PROSENSOR | Jul 29, 2009 | Substantially Equivalent |
| K072244 | PLANMECA PROONE | Sep 21, 2007 | Substantially Equivalent |
| K060328 | PLANMECA PROMAX 3D | Mar 15, 2006 | Substantially Equivalent |