The following data is part of a premarket notification filed by Toshiba Medical Systems Corporation with the FDA for Xidf-aws801, Angio Workstation, V5.31.
| Device ID | K141541 |
| 510k Number | K141541 |
| Device Name: | XIDF-AWS801, ANGIO WORKSTATION, V5.31 |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | TOSHIBA MEDICAL SYSTEMS CORPORATION 2441 MICHELLE DRIVE Tustin, CA 92780 |
| Contact | Paul Biggins |
| Correspondent | Paul Biggins TOSHIBA MEDICAL SYSTEMS CORPORATION 2441 MICHELLE DRIVE Tustin, CA 92780 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-10 |
| Decision Date | 2014-09-08 |
| Summary: | summary |