# K082243: Precision Rxi Analog and Digital X-Ray Systems

- Pathway: 510(k) (Traditional)
- Applicant: General Medical Merate S.P.A
- Decided: Nov 7, 2008 after 92 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- 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.
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’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Jun 12, 2015 · Class II · Z-2121-2015: A reported incident of a monitor that fell from the suspension. A fall of a monitor could result in an injury to a patient or operator. Recall affects the single and dual LCD monitor suspensions used 
- Jun 12, 2015 · Class II · Z-2122-2015: A reported incident of a monitor that fell from the suspension. A fall of a monitor could result in an injury to a patient or operator. Recall affects the single and dual LCD monitor suspensions used 
- Dec 12, 2013 · Class II · Z-0911-2014: GE Healthcare has recently become aware of a potential safety issue involving the Precision 500D, Precision MPI & Precision RXI X-ray imaging systems overhead LCD Video Monitor Suspension (Single moni

## Indications for use
The PRECISION RXi Analog X-ray System and PRECISION RXi Digital X-ray System are Indicated for performing general R&F, radiography, fluoroscopy, interventional and angiography procedures/applications.

Source page: https://510kreport.com/device/K082243
Methodology: https://510kreport.com/methodology