The following data is part of a premarket notification filed by Circle Cardiovascular Imaging Inc. with the FDA for Ct42 Cardiac Computed Tomography (ct) Software.
| Device ID | K111373 |
| 510k Number | K111373 |
| Device Name: | CT42 CARDIAC COMPUTED TOMOGRAPHY (CT) SOFTWARE |
| Classification | System, Image Processing, Radiological |
| Applicant | CIRCLE CARDIOVASCULAR IMAGING INC. #12, 3535 RESEARCH ROAD NW Calgary, Ab, CA T2l 2k8 |
| Contact | Shirantha Samarappuli |
| Correspondent | Shirantha Samarappuli CIRCLE CARDIOVASCULAR IMAGING INC. #12, 3535 RESEARCH ROAD NW Calgary, Ab, CA T2l 2k8 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-16 |
| Decision Date | 2011-08-23 |
| Summary: | summary |