# K012200: 1.5T Infinity Twinspeed MR System

- Pathway: 510(k) (Special)
- Applicant: GE Medical Systems
- Decided: Aug 3, 2001 after 21 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 9 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K962061 (1996). 2 ancestors in all.
103 later devices descend from it; 2 cite it directly.
3 of 106 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980114: Magnetic Resonance Diagnostic System, GE Medical Systems (1998) Summary page 1.
- K962061: Magnetic Resonance Diagnostic System, GE Medical Systems (1996) Summary page 1.

## Most influential descendants
- K013636: Signa Infinity MR System with Excite Technology (2002), 100 descendants of its own
- K041476: GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR System (2004), 99 descendants of its own
- K052293: GE 1.5T and 3.0T Signa HDX MR System (2005), 90 descendants of its own
- K081028: Signa 3.0T MR750 System (2008), 70 descendants of its own
- K083147: Discovery MR450 (2008), 69 descendants of its own

## Recalls of this device
- Feb 18, 2022 · Class II · Z-0857-2022: There is potential for the images to be flipped left to right.
- Dec 23, 2021 · Class II · Z-0604-2022: The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
- Nov 15, 2018 · Class II · Z-0693-2019: Possible incorrect software version loaded.
- Jun 7, 2018 · Class II · Z-0112-2019: The latest on-site software version may not have been reinstalled at some sites after service activities were performed resulting in images possibly flipped left/right and/or there can be patient data
- Jun 7, 2018 · Class II · Z-0110-2019: The latest on-site software version may not have been reinstalled at some sites after service activities were performed resulting in images possibly flipped left/right and/or there can be patient data
- Jun 7, 2018 · Class II · Z-0111-2019: The latest on-site software version may not have been reinstalled at some sites after service activities were performed resulting in images possibly flipped left/right and/or there can be patient data
- Jul 10, 2015 · Class II · Z-2339-2015: A gradient cable in the ACGD cabinet may be missing a spacer that prevents connecting the gradient cable terminals in the wrong polarity on X gradient amplifier. This could cause images to be flipped 
- Mar 9, 2015 · Class II · Z-1305-2015: GE Healthcare has become aware of a potential safety issue involving MRI systems due to software versions not being maintained properly at some sites.
- Jan 7, 2015 · Class I · Z-1035-2015: At certain sites, the MRU may not be connected to the magnet. In emergency situations, a disconnected MRU could delay removal of a ferrous object from the magnet, potentially resulting in life-threate

## Indications for use
The Signa 1.5T TwinSpeed Magnetic Resonance System is a whole body scanner designed for shorter scan times. The Signa TwinSpeed is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the head or body. The images produced by the Signa TwinSpeed system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.

Source page: https://510kreport.com/device/K012200
Methodology: https://510kreport.com/methodology