# K992746: Signa Hfo/I Magnetic Resonance System

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, Inc.
- Decided: Nov 9, 1999 after 85 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
No predicates in its family tree.
5 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Signa Horizon CX Magnetic Resonance System: named in the summary without a submission number
- (no number) Signa Profile Magnetic Resonance System: named in the summary without a submission number

## Most influential descendants
- K012875: Signa Openspeed Magnetic Resonance System (2001), 1 descendant of its own
- K012970: GE Signa Asset Imaging Option (2001), 1 descendant of its own
- K162403: HyperBand (2016), 0 descendants of its own
- K032795: GE 0.7T Signa Openspeed with Excite MR System (2003), 0 descendants of its own
- K022390: Hitachi Altaire (2002), 0 descendants of its own

## Recalls of this device
- Dec 23, 2021 · Class II · Z-0606-2022: 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.

## Indications for use
The Signa HFQ/i system is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times. The HFO/i 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 HFO/i 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 HFO/i 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/K992746
Methodology: https://510kreport.com/methodology