# K152184: MagView BIOMAGNETOMETER SYSTEM

- Pathway: 510(k) (Traditional)
- Applicant: Tristan Technologies, Inc.
- Decided: Apr 8, 2016 after 247 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: 3 generations back to K901215 (1990). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962317: Magnes 2500 WH Biomagnetometer, Biomagnetic Technologies, Inc. (1997) Summary page 7.

## Indications for use
Use of the MagView Biomagnetometer is indicated for the patient whose physician believes that information about the magnetic fields produced by that patient's brain and information about the location of the sources of those magnetic fields could contribute to diagnosis or therapy planning. The intended patient populations are neonates and infants and those children with head circumferences of 50 cm or less.

Source page: https://510kreport.com/device/K152184
Methodology: https://510kreport.com/methodology