# K210199: Ricoh Meg

- Pathway: 510(k) (Traditional)
- Applicant: Ricoh Company, Ltd.
- Decided: Jul 2, 2021 after 158 days
- Product code: OLX (Source Localization Software For Electroencephalograph Or 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). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040051: Megvision, Model EQ1000C Series, Eagle Technology, Inc. (2004) Summary page 4.
- K041264: Elekta OY, Elekta Neuromag OY (2004) Summary page 4.

## Indications for use
The RICOH MEG non-invasively measures the magnetoencephalographic (MEG) 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 activity 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.

Source page: https://510kreport.com/device/K210199
Methodology: https://510kreport.com/methodology