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 |