The following data is part of a premarket notification filed by Shimadzu Medical Systems with the FDA for Shimadzu Multi-directional Diagnostic Table Vs-100.
| Device ID | K913147 |
| 510k Number | K913147 |
| Device Name: | SHIMADZU MULTI-DIRECTIONAL DIAGNOSTIC TABLE VS-100 |
| Classification | Table, Radiographic, Tilting |
| Applicant | SHIMADZU MEDICAL SYSTEMS 101 WEST WALNUT ST. Gardenia, CA 90248 |
| Contact | Harry De.mint |
| Correspondent | Harry De.mint SHIMADZU MEDICAL SYSTEMS 101 WEST WALNUT ST. Gardenia, CA 90248 |
| Product Code | IXR |
| CFR Regulation Number | 892.1980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-16 |
| Decision Date | 1991-09-19 |