FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MR Core Software
K Number: K151115
·
Decision Jun 3, 2015
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
5
Review Days
37
Basic Information
- Device Name
- MR Core Software
- K Number
- K151115
- 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
- April 27, 2015
- Decision Date
- June 3, 2015
- 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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|---|---|---|---|
| K163232 | Vitrea View | Jul 21, 2017 | Substantially Equivalent |
| K150104 | Vitrea CT Myocardial Perfusion | Apr 17, 2015 | Substantially Equivalent |
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| K150258 | Vitrea, Version 7.0 Medical Image Processing Software | Mar 5, 2015 | Substantially Equivalent |