The following data is part of a premarket notification filed by Toshiba America Medical Systems, Inc. with the FDA for Infinix Angio Workstation W/dts Software.
| Device ID | K132106 |
| 510k Number | K132106 |
| Device Name: | INFINIX ANGIO WORKSTATION W/DTS SOFTWARE |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR. Tustin, CA 92780 -2068 |
| Contact | Paul Biggins |
| Correspondent | Paul Biggins TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR. Tustin, CA 92780 -2068 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-08 |
| Decision Date | 2013-11-12 |
| Summary: | summary |