The following data is part of a premarket notification filed by Canon Medical Systems Corporation with the FDA for Ultimax-i, Drex-ui80 (v1.60).
| Device ID | K181834 |
| 510k Number | K181834 |
| Device Name: | Ultimax-i, DREX-UI80 (V1.60) |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | Canon Medical Systems Corporation 1385 Shimoishigami Otawara-shi, JP 324-8550 |
| Contact | Paul Biggins |
| Correspondent | Paul Biggins Canon Mecial Systems, U.S., Inc. 2441 Michelle Drive Tustin, CA 92780 |
| Product Code | OWB |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-10 |
| Decision Date | 2018-07-19 |
| Summary: | summary |