The following data is part of a premarket notification filed by Toshiba Medical Systems Corporation with the FDA for Ultimax-i.
| Device ID | K143281 |
| 510k Number | K143281 |
| Device Name: | Ultimax-i |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | TOSHIBA MEDICAL SYSTEMS CORPORATION 1385 SHIMOISHIGAMI Otawara-shi, JP 324-8550 |
| Contact | Paul Biggins |
| Correspondent | Paul Biggins TOSHIBA AMERICAN MEDICAL SYSTEMS, INC. 2441 MICHELLE DRIVE Tustin, CA 92780 |
| Product Code | OWB |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-14 |
| Decision Date | 2015-01-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987670100147 | K143281 | 000 |