The following data is part of a premarket notification filed by Canon Medical Systems Usa with the FDA for Aquilion One Self-propelled Scan Base Kit For Ivr-ct, Cgba-034a.
| Device ID | K182223 |
| 510k Number | K182223 |
| Device Name: | Aquilion ONE Self-Propelled Scan Base Kit For IVR-CT, CGBA-034A |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | Canon Medical Systems USA 1385 Shimoishigami Otawara-shi, JP 324-8550 |
| Contact | Paul Biggins |
| Correspondent | Orlando Tadeo Canon Medical Systems USA 2441 Michelle Drive Tustin, CA 92780 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-16 |
| Decision Date | 2018-09-14 |
| Summary: | summary |