The following data is part of a premarket notification filed by Shimadzu Corp. with the FDA for Lateral Angiographic C-arm Support Mh-400.
| Device ID | K033184 |
| 510k Number | K033184 |
| Device Name: | LATERAL ANGIOGRAPHIC C-ARM SUPPORT MH-400 |
| Classification | System, X-ray, Angiographic |
| Applicant | SHIMADZU CORP. 20101 SOUTH VERMONT AVE. Torrance, CA 90502 -1328 |
| Contact | Takeshi Ozaki |
| Correspondent | Takeshi Ozaki SHIMADZU CORP. 20101 SOUTH VERMONT AVE. Torrance, CA 90502 -1328 |
| Product Code | IZI |
| CFR Regulation Number | 892.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-01 |
| Decision Date | 2003-12-09 |