The following data is part of a premarket notification filed by Toshiba America Medical Systems, Inc. with the FDA for 3d Angiographic Imaging System, Model Xidf-100a.
| Device ID | K002424 |
| 510k Number | K002424 |
| Device Name: | 3D ANGIOGRAPHIC IMAGING SYSTEM, MODEL XIDF-100A |
| Classification | System, Image Processing, Radiological |
| Applicant | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR. P.O. BOX 2068 Tustin, CA 92781 -2068 |
| Contact | Diana Thorson |
| Correspondent | Diana Thorson TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR. P.O. BOX 2068 Tustin, CA 92781 -2068 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-08 |
| Decision Date | 2000-10-27 |