The following data is part of a premarket notification filed by Ge Medical Systems with the FDA for Tc+ System (tilting C-arm System).
| Device ID | K936180 |
| 510k Number | K936180 |
| Device Name: | TC+ SYSTEM (TILTING C-ARM SYSTEM) |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | GE MEDICAL SYSTEMS 3000 N GRANDVIEW BLVD. W-709 Waukesha, WI 53188 |
| Product Code | OWB |
| Subsequent Product Code | JAA |
| Subsequent Product Code | OXO |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-27 |
| Decision Date | 1994-03-16 |