# K962317: Magnes 2500 WH Biomagnetometer

- Pathway: 510(k) (Traditional)
- Applicant: Biomagnetic Technologies, Inc.
- Decided: May 7, 1997 after 324 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: 2 generations back to K901215 (1990). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941553: Magnes II Biomagnetometer, Biomagnetic Technologies, Inc. (1996) Summary page 1.

## Most influential descendants
- K152184: MagView BIOMAGNETOMETER SYSTEM (2016), 0 descendants of its own
- K133419: Babymeg Biomagnetometer System (2014), 0 descendants of its own

## Indications for use
Use of the Magnes 2500 WH 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.

Source page: https://510kreport.com/device/K962317
Methodology: https://510kreport.com/methodology