The following data is part of a premarket notification filed by Toshiba Medical Systems Corporation with the FDA for Digital Radiography System With Flat Panel Detector, Model Dfp8000d.
| Device ID | K041027 |
| 510k Number | K041027 |
| Device Name: | DIGITAL RADIOGRAPHY SYSTEM WITH FLAT PANEL DETECTOR, MODEL DFP8000D |
| Classification | System, X-ray, Angiographic |
| Applicant | TOSHIBA MEDICAL SYSTEMS CORPORATION 2441 MICHELLE DRIVE Tustin, CA 92780 |
| Contact | Michaela Mahl |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | IZI |
| CFR Regulation Number | 892.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-04-21 |
| Decision Date | 2004-05-14 |
| Summary: | summary |