The following data is part of a premarket notification filed by Shimadzu Corp. with the FDA for Mobile X-ray Television Unit Wha-10a/b.
| Device ID | K895394 |
| 510k Number | K895394 |
| Device Name: | MOBILE X-RAY TELEVISION UNIT WHA-10A/B |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | SHIMADZU CORP. 1 NISHINOKYO-KUWABARACHO NAKAYGO-KU Kyoto City 604 Japan, JP |
| Contact | Masao Yoshimura |
| Correspondent | Masao Yoshimura SHIMADZU CORP. 1 NISHINOKYO-KUWABARACHO NAKAYGO-KU Kyoto City 604 Japan, JP |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-06 |
| Decision Date | 1989-11-13 |