The following data is part of a premarket notification filed by Shimadzu Corp. with the FDA for Shimadzu Mobile X-ray System Mux-100d Series.
| Device ID | K041763 |
| 510k Number | K041763 |
| Device Name: | SHIMADZU MOBILE X-RAY SYSTEM MUX-100D SERIES |
| Classification | System, X-ray, Mobile |
| Applicant | SHIMADZU CORP. 20101 SOUTH VERMONT AVE. Torrance, CA 90502 -1328 |
| Contact | Takeshi Ozaki |
| Correspondent | Tamas Borsai TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-06-30 |
| Decision Date | 2004-07-13 |