FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UroNav System
K Number: K193403
·
Decision Dec 27, 2019
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
7
Review Days
21
Basic Information
- Device Name
- UroNav System
- K Number
- K193403
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Invivo Corporation
- Date Received
- December 6, 2019
- Decision Date
- December 27, 2019
- Product Code
- LLZ
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- Y
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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LLZ), ordered by most recent decision date.
CustomSurg OrthoPlanner
FDA 510(k)
FDA Class 2
·Radiology
uOmniscan
FDA 510(k)
FDA Class 2
·Radiology
Mosaic (V1.0.1)
FDA 510(k)
FDA Class 2
·Radiology
UroNav 4
FDA 510(k)
FDA Class 2
·Radiology
TechLive
FDA 510(k)
FDA Class 2
·Radiology
SMARTDent
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Invivo Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K213766 | dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for 1.5T and 3.0T, ds Small Extremity 16Ch Coils for 1.5T and 3.0T | Dec 23, 2021 | Substantially Equivalent |
| K212227 | Philips MR Patient Care Portal | Sep 30, 2021 | Substantially Equivalent |
| K212175 | DynaCAD | Aug 2, 2021 | Substantially Equivalent |
| K192200 | DynaCAD | Oct 9, 2019 | Substantially Equivalent |
| K182561 | UroNav (Version 3.0) | Oct 19, 2018 | Substantially Equivalent |
| K162177 | dS FootAnkle I6CH 1.5T Coil | Sep 14, 2016 | Substantially Equivalent |