The following data is part of a premarket notification filed by Circle Cardiovascular Imaging Inc. with the FDA for Cmr42 Cardiac Mri Imaging System, 2.1.23.
| Device ID | K082628 |
| 510k Number | K082628 |
| Device Name: | CMR42 CARDIAC MRI IMAGING SYSTEM, 2.1.23 |
| Classification | System, Image Processing, Radiological |
| Applicant | CIRCLE CARDIOVASCULAR IMAGING INC. SUITE 130, 31 STREET NW Calgary, Alberta, CA T2l 2k7 |
| Contact | Shirantha Samarappuli |
| Correspondent | Shirantha Samarappuli CIRCLE CARDIOVASCULAR IMAGING INC. SUITE 130, 31 STREET NW Calgary, Alberta, CA T2l 2k7 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-09 |
| Decision Date | 2008-11-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00882916000011 | K082628 | 000 |
| 00882916000028 | K082628 | 000 |