FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ADVANCED DIAGNOSTIC VIEWER (AOX), MODEL VITRED 1.3
K Number: K990442
·
Decision May 11, 1999
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
30
Review Days
90
Basic Information
- Device Name
- ADVANCED DIAGNOSTIC VIEWER (AOX), MODEL VITRED 1.3
- K Number
- K990442
- 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
- February 10, 1999
- Decision Date
- May 11, 1999
- 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 |
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 VITAL IMAGES, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K161157 | Vitrea CT Dual Energy Image View | Nov 3, 2016 | Substantially Equivalent |
| K161419 | Multi Modality Viewer | Jul 13, 2016 | Substantially Equivalent |
| K151919 | Vitrea CT Lung Density Analysis Software | Oct 10, 2015 | Substantially Equivalent |
| K143079 | Endovascular Stent Planning Software | Dec 4, 2014 | Substantially Equivalent |
| K141302 | VITREA CT MULTI-CHAMBER CARDIAC FUNCTIONAL ANALYSIS (CFA) | Aug 1, 2014 | Substantially Equivalent |
| K140395 | VITREA IMAGE DENOISING SOFTWARE | May 13, 2014 | Substantially Equivalent |
| K122578 | VITREA CT TRANSCATHETER AORTIC VALVE REPLACMENT (TAVR) PLANNING | Feb 25, 2013 | Substantially Equivalent |
| K121213 | VITREAADVANCED | Nov 2, 2012 | Substantially Equivalent |
| K122136 | VITREAVIEW | Sep 7, 2012 | Substantially Equivalent |
| K112531 | VITREA CT MYOCARDIAL ANALYSIS | Nov 18, 2011 | Substantially Equivalent |