The following data is part of a premarket notification filed by Shimadzu Corp. with the FDA for Catheterization C-arm Support Mh-51bm/mh-51cm.
| Device ID | K933473 |
| 510k Number | K933473 |
| Device Name: | CATHETERIZATION C-ARM SUPPORT MH-51BM/MH-51CM |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | SHIMADZU CORP. 1 NISHINOKYO-KUWABARACHO NAKAYGO-KU Kyoto City 604 Japan, JP |
| Contact | Hiroslhi Iskhihara |
| Correspondent | Hiroslhi Iskhihara 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 | 1993-07-15 |
| Decision Date | 1993-11-24 |