The following data is part of a premarket notification filed by Shimadzu Corp. with the FDA for Digital Angiography System Digitex Safire.
| Device ID | K032443 |
| 510k Number | K032443 |
| Device Name: | DIGITAL ANGIOGRAPHY SYSTEM DIGITEX SAFIRE |
| Classification | System, X-ray, Angiographic |
| Applicant | SHIMADZU CORP. 20101 SOUTH VERMONT AVE. Torrance, CA 90502 -1328 |
| Contact | Takeshi Ozaki |
| Correspondent | Takeshi Ozaki SHIMADZU CORP. 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 | 2003-08-08 |
| Decision Date | 2004-02-20 |