The following data is part of a premarket notification filed by Shimadzu Medical Systems with the FDA for Shimadzu X-ray Diagnostic Table Ysf-120.
Device ID | K963617 |
510k Number | K963617 |
Device Name: | SHIMADZU X-RAY DIAGNOSTIC TABLE YSF-120 |
Classification | System, X-ray, Fluoroscopic, Image-intensified |
Applicant | SHIMADZU MEDICAL SYSTEMS 20101 SOUTH VERMONT AVE. Torrance, CA 90502 -1328 |
Contact | Michael Fishback |
Correspondent | Michael Fishback SHIMADZU MEDICAL SYSTEMS 20101 SOUTH VERMONT AVE. Torrance, CA 90502 -1328 |
Product Code | JAA |
CFR Regulation Number | 892.1650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-09-10 |
Decision Date | 1996-11-08 |