The following data is part of a premarket notification filed by Shimadzu Corp. with the FDA for Mobile X-ray System.
| Device ID | K955036 |
| 510k Number | K955036 |
| Device Name: | MOBILE X-RAY SYSTEM |
| Classification | System, X-ray, Mobile |
| Applicant | SHIMADZU CORP. 1 NISHINOKYO-KUWABARACHO NAKAYGO-KU Kyoto City 604 Japan, JP |
| Contact | Hiroshi Ishihara |
| Correspondent | Hiroshi Ishihara SHIMADZU CORP. 1 NISHINOKYO-KUWABARACHO NAKAYGO-KU Kyoto City 604 Japan, JP |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-03 |
| Decision Date | 1995-12-22 |