The following data is part of a premarket notification filed by Shimadzu Medical Systems with the FDA for C-arm Table Ivs-100.
| Device ID | K963888 |
| 510k Number | K963888 |
| Device Name: | C-ARM TABLE IVS-100 |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| 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 | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-26 |
| Decision Date | 1996-12-18 |