The following data is part of a premarket notification filed by Canon Medical Informatics, Inc. with the FDA for Vitrea Ct Cardiac Analysis.
| Device ID | K222662 |
| 510k Number | K222662 |
| Device Name: | Vitrea CT Cardiac Analysis |
| Classification | System, Image Processing, Radiological |
| Applicant | Canon Medical Informatics, Inc. 5850 Opus Parkway, Suite 300 Minnetonka, MN 55343 |
| Contact | Jay Vaishnav |
| Correspondent | Jay Vaishnav Canon Medical Informatics, Inc. 5850 Opus Parkway, Suite 300 Minnetonka, MN 55343 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-09-02 |
| Decision Date | 2022-10-14 |