The following data is part of a premarket notification filed by Toshiba America Medical Systems, Inc. with the FDA for Digital Radiography System, Model Dfp-8000d.
| Device ID | K013608 |
| 510k Number | K013608 |
| Device Name: | DIGITAL RADIOGRAPHY SYSTEM, MODEL DFP-8000D |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR. P.O. BOX 2068 Tustin, CA 92781 -2068 |
| Contact | Diana Thorson |
| Correspondent | Mark Job TUV PRODUCT SERVICE, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | OWB |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2001-10-31 |
| Decision Date | 2001-11-15 |
| Summary: | summary |