FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VITREA CT TRANSCATHETER AORTIC VALVE REPLACMENT (TAVR) PLANNING
K Number: K122578
·
Decision Feb 25, 2013
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
30
Review Days
186
Basic Information
- Device Name
- VITREA CT TRANSCATHETER AORTIC VALVE REPLACMENT (TAVR) PLANNING
- K Number
- K122578
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- VITAL IMAGES, INC.
- Date Received
- August 23, 2012
- Decision Date
- February 25, 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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| K121213 | VITREAADVANCED | Nov 2, 2012 | Substantially Equivalent |
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| K112531 | VITREA CT MYOCARDIAL ANALYSIS | Nov 18, 2011 | Substantially Equivalent |
| K111892 | VITREAVIEW SOFTWARE 6.1 | Jul 28, 2011 | Substantially Equivalent |