The following data is part of a premarket notification filed by Toshiba Medical Systems Corporation with the FDA for Cgba-032a, Aquilion Prime Self-propelled Scan Base Kit For Ivr-ct.
| Device ID | K143223 |
| 510k Number | K143223 |
| Device Name: | CGBA-032A, Aquilion PRIME Self-Propelled Scan Base Kit For IVR-CT |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | TOSHIBA MEDICAL SYSTEMS CORPORATION 1385 SHIMOISHIGAMI Otawara-shi, JP 324-8550 |
| Contact | Paul Biggins |
| Correspondent | Paul Biggins TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 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 | 2014-11-10 |
| Decision Date | 2015-01-12 |
| Summary: | summary |