# K033486: GE Precision Mpi

- Pathway: 510(k) (Traditional)
- Applicant: Nrt-Nordisk Rontgen Teknik A/S
- Decided: Nov 19, 2003 after 15 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K961374 (1996). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961374: Philips Multidiagnost 4, Philips Medical Systems, Inc. (1996) Summary page 1.

## Most influential descendants
- K173631: Intelli-C (2018), 0 descendants of its own

## Recalls of this device
- Jun 12, 2015 · Class II · Z-2123-2015: 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
- May 1, 2009 · Not classified · Z-1658-2009: The GE Precision MPi is in violation with 21 CFR Part 1020.32 requiring a signal audible to the fluoroscopist to sound for each passage of 5 minutes of fluoroscopic irradiation time during an examinat
- Jul 1, 2008 · Class II · Z-0753-2016: It was discovered that the Remote Touch Panel (RTP) of the GE Precision MPi X-ray system may not always boot up as intended and needs to be updated to properly accomplish its intended purpose.
- May 1, 2008 · Not classified · Z-2143-2008: The Precision MPi collimator did not contain a label identifying the device as being certified to comply with applicable requirements of the x-ray performance standard.
- May 1, 2008 · Not classified · Z-2144-2008: The Precision MPi collimator did not contain a label identifying the device as being certified to comply with applicable requirements of the x-ray performance standard.
- May 1, 2008 · Not classified · Z-2142-2008: The Precision MPi collimator did not contain a label identifying the device as being certified to comply with applicable requirements of the x-ray performance standard.

## Indications for use
The GE Precision MPi is a multi-purpose system that can perform general R&F, radiography, fluoroscopy, interventional and angiography procedures/applications.

Source page: https://510kreport.com/device/K033486
Methodology: https://510kreport.com/methodology