The following data is part of a premarket notification filed by Shimadzu Medical Systems with the FDA for Dar-8000f.
| Device ID | K052500 |
| 510k Number | K052500 |
| Device Name: | DAR-8000F |
| Classification | System, X-ray, Angiographic |
| Applicant | SHIMADZU MEDICAL SYSTEMS 20101 SOUTH VERMONT AVE. Torrance, CA 90502 -1328 |
| Contact | Randal Walker |
| Correspondent | Randal Walker SHIMADZU MEDICAL SYSTEMS 20101 SOUTH VERMONT AVE. Torrance, CA 90502 -1328 |
| Product Code | IZI |
| CFR Regulation Number | 892.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-13 |
| Decision Date | 2005-10-17 |