FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
3D PROSTATE SUITE 3DTRUS PROSTATE MAPPING, MRI/3DTRUS FUSION OPTION, SECOND LOOK 3DTRUS FUSION OPTION
K Number: K131448
·
Decision Jul 26, 2013
Classifications
1
FEI Numbers
599
Registration Numbers
599
Same Product Code
2271
Applicant Total
7
Review Days
67
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Basic Information
- Device Name
- 3D PROSTATE SUITE 3DTRUS PROSTATE MAPPING, MRI/3DTRUS FUSION OPTION, SECOND LOOK 3DTRUS FUSION OPTION
- K Number
- K131448
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Koelis
- Date Received
- May 20, 2013
- Decision Date
- July 26, 2013
- 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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|---|---|---|---|
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| K171040 | Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range | Jul 31, 2017 | Substantially Equivalent |
| K170521 | TRINITY/3D PROSTATE SUITE | May 30, 2017 | Substantially Equivalent |
| K160357 | TRINITY | May 2, 2016 | Substantially Equivalent |
| K141334 | REUSABLE GUIDE | Jul 11, 2014 | Substantially Equivalent |
| K100793 | UROSTATION 3D PROSTATE SUITE | Sep 22, 2010 | Substantially Equivalent |