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 |