The following data is part of a premarket notification filed by Shimadzu Precision Instruments, Inc. with the FDA for Shimadzu Mobile X-ray Systems.
Device ID | K940294 |
510k Number | K940294 |
Device Name: | SHIMADZU MOBILE X-RAY SYSTEMS |
Classification | Image-intensified Fluoroscopic X-ray System, Mobile |
Applicant | SHIMADZU PRECISION INSTRUMENTS, INC. 21010 SOUTH VERMONT AVE. Torrance, CA 90502 |
Contact | Micharl Y Fishback |
Correspondent | Micharl Y Fishback SHIMADZU PRECISION INSTRUMENTS, INC. 21010 SOUTH VERMONT AVE. Torrance, CA 90502 |
Product Code | OXO |
CFR Regulation Number | 892.1650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-01-21 |
Decision Date | 1994-03-16 |