# K936180: TC+ System (Tilting C-Arm System)

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems
- Decided: Mar 16, 1994 after 79 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Nov 8, 2013 · Class II · Z-0804-2014: Missing screws in the overhead Video Monitor Suspension. GE discovered that the 4 outer screws that hold the overhead Video Monitor Suspension to the carriage were missing since installation of the sy

Source page: https://510kreport.com/device/K936180
Methodology: https://510kreport.com/methodology