FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Vitrea CT Myocardial Perfusion
K Number: K150104
·
Decision Apr 17, 2015
Classifications
1
FEI Numbers
163
Registration Numbers
163
Same Product Code
818
Applicant Total
41
Review Days
87
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Basic Information
- Device Name
- Vitrea CT Myocardial Perfusion
- K Number
- K150104
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1750
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vital Images, Inc.
- Date Received
- January 20, 2015
- Decision Date
- April 17, 2015
- Product Code
- JAK
- 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 |
|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | FDA class 2 | Radiology |
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Other Clearances by Vital Images, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K181247 | Vitrea CT Brain Perfusion | Nov 20, 2018 | Substantially Equivalent |
| K182230 | Multi Modality Viewer | Sep 7, 2018 | Substantially Equivalent |
| K172855 | Vitrea Advanced Visualization, Version 7.6 | Oct 5, 2017 | Substantially Equivalent |
| K163232 | Vitrea View | Jul 21, 2017 | Substantially Equivalent |
| K163574 | Multi Modality Viewer | Jan 26, 2017 | Substantially Equivalent |
| K161157 | Vitrea CT Dual Energy Image View | Nov 3, 2016 | Substantially Equivalent |
| K161419 | Multi Modality Viewer | Jul 13, 2016 | Substantially Equivalent |
| K160150 | Vitrea CT Colon Analysis | Mar 16, 2016 | Substantially Equivalent |
| K151283 | Lung Analysis Software | Oct 30, 2015 | Substantially Equivalent |
| K151919 | Vitrea CT Lung Density Analysis Software | Oct 10, 2015 | Substantially Equivalent |