The following data is part of a premarket notification filed by Canon Medical Systems Corporation with the FDA for Vitrea Software Package, Vstp-001a.
| Device ID | K183013 |
| 510k Number | K183013 |
| Device Name: | Vitrea Software Package, VSTP-001A |
| Classification | System, Image Processing, Radiological |
| Applicant | Canon Medical Systems Corporation 1385 Shimoishigami Otawara, JP 324-8550 |
| Contact | Paul Biggins |
| Correspondent | Paul Biggins Canon Medical Systems U.S.A 2441 Michelle Drive Tustin, CA 92780 |
| Product Code | LLZ |
| Subsequent Product Code | IYL |
| Subsequent Product Code | IYN |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-31 |
| Decision Date | 2018-11-26 |
| Summary: | summary |