FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UroNav (Version 2.0)
K Number: K153073
·
Decision Nov 16, 2015
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
22
Review Days
25
Basic Information
- Device Name
- UroNav (Version 2.0)
- K Number
- K153073
- 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
- October 22, 2015
- Decision Date
- November 16, 2015
- 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 | ||
|---|---|---|---|
| K162001 | 1.5T and 3.0T 16 CH GE Shoulder Coils | Aug 31, 2016 | Substantially Equivalent |
| K152330 | Expression MR400 MRI Patient Monitoring System | Dec 23, 2015 | Substantially Equivalent |
| K133030 | DYNACAD/PROSTATE INTERVENTIONAL (DYNALOC/PROSTATE) | Jan 22, 2014 | Substantially Equivalent |
| K132359 | MRI PATIENT MONITORING SYSTEM | Aug 30, 2013 | Substantially Equivalent |
| K131382 | EXPRESSION MR200 MRI PATIENT MONITORING SYSTEM, EXPRESSION IP5 INFORMATION PORTAL | Jul 15, 2013 | Substantially Equivalent |
| K124061 | MRI PATIENT MONITORING SYSTEM (MODEL 865214) | Feb 22, 2013 | Substantially Equivalent |
| K122897 | SENSE HEAD 16 MODEL 800647, SENSE SPINE 16 MODEL 800646; SENSE TORSO 16 MODEL 800645 | Dec 21, 2012 | Substantially Equivalent |
| K122646 | DS BREAST 16CH I/T 1.5T DS BREAST 16CH I/T 3.0T | Nov 2, 2012 | Substantially Equivalent |
| K121424 | EXPRESSION INFORMATION PORTAL | Jun 13, 2012 | Substantially Equivalent |
| K120122 | SENSE MSK S 8CH 1.5T | Feb 10, 2012 | Substantially Equivalent |