# K943805: Prestige Remote R & F System Models H, VH & VHD

- Pathway: 510(k) (Traditional)
- Applicant: General Electric Co.
- Decided: Sep 23, 1994 after 50 days
- Product code: JAA (System, X-Ray, Fluoroscopic, Image-Intensified)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K061028: Precision Thunis 800+ (2006), 0 descendants of its own

## Recalls of this device
- Mar 29, 2019 · Class II · Z-1751-2019: There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging.
- Nov 21, 2016 · Class II · Z-0912-2017: 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 21, 2016 · Class II · Z-0913-2017: 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 21, 2016 · Class II · Z-0911-2017: 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/K943805
Methodology: https://510kreport.com/methodology