# K041605: Precision Rxi Analog X-Ray System

- Pathway: 510(k) (Traditional)
- Applicant: General Medical Merate S.P.A
- Decided: Jun 30, 2004 after 15 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- 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.
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
- May 1, 2008 · Not classified · Z-2145-2008: The Precision RXi collimator did not contain a label identifying the device as being certified to comply with applicable requirements of the x-ray performance standard.
- Dec 18, 2007 · Not classified · Z-1565-2008: GE Healthcare Precision RXi tilt joystick became stuck in the Trendelenburg direction causing the patient to slide off the table. Also recall conducted to investigate the possibility of accidentally a
- Dec 18, 2007 · Not classified · Z-1563-2008: GE Healthcare Precision RXi tilt joystick became stuck in the Trendelenburg direction causing the patient to slide off the table. Also recall conducted to investigate the possibility of accidentally a
- Dec 18, 2007 · Not classified · Z-1564-2008: GE Healthcare Precision RXi tilt joystick became stuck in the Trendelenburg direction causing the patient to slide off the table. Also recall conducted to investigate the possibility of accidentally a
- Nov 1, 2006 · Not classified · Z-1485-06: Automatic exposure control (AEC) automatically resets allowing another exposure without requiring manual reset as specified in 21 CFR 1020.31 (a)(3)(iv)

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

Source page: https://510kreport.com/device/K041605
Methodology: https://510kreport.com/methodology