K082628 is an FDA 510(k) clearance for the CMR42 CARDIAC MRI IMAGING SYSTEM, 2.1.23. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).
Submitted by Circle Cardiovascular Imaging, Inc. (Calgary, Alberta, CA). The FDA issued a Cleared decision on November 20, 2008, 72 days after receiving the submission on September 9, 2008.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.
| 510(k) Number | K082628 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 09, 2008 |
| Decision Date | November 20, 2008 |
| Days to Decision | 72 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | LLZ — System, Image Processing, Radiological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2050 |