The following data is part of a premarket notification filed by Shimadzu Medical Systems with the FDA for Shimadzu Image Processor Dfs-500.
| Device ID | K905132 |
| 510k Number | K905132 |
| Device Name: | SHIMADZU IMAGE PROCESSOR DFS-500 |
| Classification | System, Image Processing, Radiological |
| 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 | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-15 |
| Decision Date | 1991-04-16 |