# K012875: Signa Openspeed Magnetic Resonance System

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems
- Decided: Nov 20, 2001 after 85 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K992746 (1999). 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)
- K992746: Signa Hfo/I Magnetic Resonance System, Ge Medical Systems, Inc. (1999) Summary page 1.

## Most influential descendants
- K032795: GE 0.7T Signa Openspeed with Excite MR System (2003), 0 descendants of its own

## Recalls of this device
- Dec 23, 2021 · Class II · Z-0607-2022: The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.

## Indications for use
The Signa OpenSpeed Magnetic Resonance System is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times. The Signa OpenSpeed Magnetic Resonance System is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures and organs of the entire body, including, but not limited to, the musculocskeletal, vascular, cardiac, and neuro systems. The images produced by the Signa OpenSpeed 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. Due to the ‘open’ design of the system, the Signa OpenSpeed may also be used for imaging during interventional procedures when performed with MR compatible devices such as, in-room display and MR safe biopsy needles.

Source page: https://510kreport.com/device/K012875
Methodology: https://510kreport.com/methodology