# K013858: Infinion 0.6T MR Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems (Cleveland), Inc.
- Decided: Jan 22, 2002 after 62 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K931544 (1993). 6 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974844: Outlook System Enhancement Package, Philips Medical Systems (Cleveland), Inc. (1998) Summary page 2.

## Most influential descendants
- K024042: Panorama Enhancements (2003), 4 descendants of its own
- K071154: Superstar 0.35T Mri System (2007), 3 descendants of its own
- K131737: Supernova C5 Mri System (2014), 0 descendants of its own
- K092237: NSM-S15 System (2009), 0 descendants of its own
- K082485: Modification to Superopen 0.23T Mri System, Model Nam-P023A (2008), 0 descendants of its own

## Recalls of this device
- Aug 7, 2013 · Class II · Z-0033-2014: There is a potential for water to collect in the vent pipe elbow in the magnet venting system. Water may freeze, blocking the venting system.
- Sep 19, 2008 · Not classified · Z-2434-2010: Water may collect and freeze in the vent pipe. This can rupture the magnet vessel during a cryogen transfer, and release helium into the MRI suite.

## Indications for use
The Infinion 0.6T MR Imaging System does not change the existing indications as defined below. The Infinion 0.6T MR Imaging System is indicated for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1), and spin-spin relaxation time (T2)) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.

Source page: https://510kreport.com/device/K013858
Methodology: https://510kreport.com/methodology