The following data is part of a premarket notification filed by Shimadzu Corp. with the FDA for Shimadzu Surgical Mobile C-arm Imaging X-ray System, Model Wha-200.
| Device ID | K043379 |
| 510k Number | K043379 |
| Device Name: | SHIMADZU SURGICAL MOBILE C-ARM IMAGING X-RAY SYSTEM, MODEL WHA-200 |
| Classification | Image-intensified Fluoroscopic X-ray System, Mobile |
| Applicant | SHIMADZU CORP. 20101 SOUTH VERMONT AVE. Torrance, CA 90502 -1328 |
| Contact | Randal Walker |
| Correspondent | Randal Walker SHIMADZU CORP. 20101 SOUTH VERMONT AVE. Torrance, CA 90502 -1328 |
| Product Code | OXO |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-08 |
| Decision Date | 2005-02-17 |