# K862120: SCX System

- Pathway: 510(k) (Traditional)
- Applicant: General Electric Co.
- Decided: Jun 16, 1986 after 13 days
- Product code: JAA (System, X-Ray, Fluoroscopic, Image-Intensified)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
227 later devices descend from it; 2 cite it directly.
0 of 228 devices 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.

## Most influential descendants
- K982196: Digital Radiographic Imaging System (1998), 221 descendants of its own
- K992066: Revolution TX/I Digital Radiographic Table System (1999), 104 descendants of its own
- K012389: Revolution XR/D Digital Radiographic Imaging System (2001), 103 descendants of its own
- K992794: Stingray DR, Model 1 (1999), 103 descendants of its own
- K024147: Paxscan 4030 Medical Digital Imaging System (2003), 78 descendants of its own

## Recalls of this device
- Feb 6, 2017 · Class II · Z-2179-2017: Reported incidents of a patient step detaching from the table. A fall from a patient step detaching while in use could result in an injury to a patient or operator.
- Nov 21, 2016 · Class II · Z-0909-2017: GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, ADVANTX and Innova 2000 systems.
- 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/K862120
Methodology: https://510kreport.com/methodology