FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CARDIO VUE QUANTITATIVE ANALYSIS (CVQ)
K Number: K082526
·
Decision Jan 5, 2009
Classifications
1
FEI Numbers
599
Registration Numbers
599
Same Product Code
2271
Applicant Total
2
Review Days
125
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Basic Information
- Device Name
- CARDIO VUE QUANTITATIVE ANALYSIS (CVQ)
- K Number
- K082526
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mri Cardiac Services, Incorporated
- Date Received
- September 2, 2008
- Decision Date
- January 5, 2009
- 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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Other Clearances by Mri Cardiac Services, Incorporated
| K Number | Device Name | ||
|---|---|---|---|
| K060840 | SVIEW | Apr 7, 2006 | Substantially Equivalent |