# K012970: GE Signa Asset Imaging Option

- Pathway: 510(k) (Special)
- Applicant: GE Medical Systems
- Decided: Sep 24, 2001 after 20 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K962061 (1996). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 9 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012200: 1.5T Infinity Twinspeed MR System, GE Medical Systems (2001) Summary page 1.
- K990550: 3.0T Signa VH/I Magnetic Resonance System, Ge Medical Systems, Inc. (1999) Summary page 1.
- K003575: Modification to 3.0T Signa VH/I Magnetic Resonance System, GE Medical Systems (2001) Summary page 1.
- K003613: 3.0.T Signa VH/I (T/R) Body Imaging Coil, GE Medical Systems (2001). Our OCR of the scanned summary read K006313, which is not a number in FDA’s lists. Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Signa VH/i MR System”.
- K992746: Signa Hfo/I Magnetic Resonance System, Ge Medical Systems, Inc. (1999) Summary page 1.

## Most influential descendants
- K162403: HyperBand (2016), 0 descendants of its own

## Indications for use
The Signa Magnetic Resonance System is a whole body scanner. The Signa Magnetic Resonance System 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 Magnetic Resonance 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/K012970
Methodology: https://510kreport.com/methodology