The following data is part of a premarket notification filed by Shimadzu Medical Systems with the FDA for Shimadzu Digital Subtraction System Dar-2400.
| Device ID | K903941 |
| 510k Number | K903941 |
| Device Name: | SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-2400 |
| Classification | System, X-ray, Angiographic |
| Applicant | SHIMADZU MEDICAL SYSTEMS 101 WEST WALNUT ST. Gardenia, CA 90248 |
| Contact | De Mint |
| Correspondent | De Mint SHIMADZU MEDICAL SYSTEMS 101 WEST WALNUT ST. Gardenia, CA 90248 |
| Product Code | IZI |
| CFR Regulation Number | 892.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-27 |
| Decision Date | 1991-02-04 |