# K191785: Orion LifeSpan MEG

- Pathway: 510(k) (Traditional)
- Applicant: Compumedics Limited
- Decided: Feb 14, 2020 after 226 days
- Product code: OLY (Magnetoencephalograph)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K901215 (1990). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041264: Elekta OY, Elekta Neuromag OY (2004) Summary page 4.

## Indications for use
The Orion LifeSpan MEG non-invasively measures the magnetoencephalographic (MEG) (and, optionally, electroencephalographic (EEG) signals) produced by electrically active tissue of the brain. These signals are recorded by a computerized data acquisition system, displayed, and may then be interpreted by trained physicians to help localize these active areas. The locations may then be correlated with anatomical information of the brain. MEG is routinely used to identify the locations of visual, auditory, and somatosensory in the brain when used in conjunction with evoked response averaging devices. MEG is also used to non-invasively locate regions of epileptic activity within the brain. The localization information provided by the device may be used, in conjunction with other diagnostic data, as an aid in neurosurgical planning. It is assumed that the users of the Orion LifeSpan™ MEG are physicians or neurology laboratory technicians who have received training in the following areas: • Hospital procedures • Physiological monitoring of patients • Training relevant to the specific discipline or disorder under investigation Note: This indication for use specifically excludes use of the Orion LifeSpan™ MEG as life support equipment, for example vital signs monitoring in intensive care units.

Source page: https://510kreport.com/device/K191785
Methodology: https://510kreport.com/methodology