The following data is part of a premarket notification filed by Shimadzu Medical Systems with the FDA for Ceiling Suspended C-arm Support Mh-100.
| Device ID | K943545 |
| 510k Number | K943545 |
| Device Name: | CEILING SUSPENDED C-ARM SUPPORT MH-100 |
| Classification | System, X-ray, Angiographic |
| Applicant | SHIMADZU MEDICAL SYSTEMS 20101 SOUTH VERMONT AVE. Torrance, CA 90502 -1328 |
| Contact | Michael Fishback |
| Correspondent | Michael Fishback SHIMADZU MEDICAL SYSTEMS 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 | 1994-07-21 |
| Decision Date | 1995-02-03 |