The following data is part of a premarket notification filed by Mri Cardiac Services, Incorporated with the FDA for Cardio Vue Quantitative Analysis (cvq).
| Device ID | K082526 |
| 510k Number | K082526 |
| Device Name: | CARDIO VUE QUANTITATIVE ANALYSIS (CVQ) |
| Classification | System, Image Processing, Radiological |
| Applicant | MRI CARDIAC SERVICES, INCORPORATED 8 WEST THIRD ST. SUITE M9 Winston-salem, NC 27101 |
| Contact | Scott Huber |
| Correspondent | Scott Huber MRI CARDIAC SERVICES, INCORPORATED 8 WEST THIRD ST. SUITE M9 Winston-salem, NC 27101 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-02 |
| Decision Date | 2009-01-05 |
| Summary: | summary |