# K941553: Magnes II Biomagnetometer

- Pathway: 510(k) (Traditional)
- Applicant: Biomagnetic Technologies, Inc.
- Decided: May 16, 1996 after 778 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: 1 generation back to K901215 (1990). 1 ancestor in all.
3 later devices descend from it; 1 cites 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)
- K901215: 700 Series Biomagnetometer, Biomagnetic Technologies, Inc. (1990)

## Most influential descendants
- K962317: Magnes 2500 WH Biomagnetometer (1997), 2 descendants of its own
- K152184: MagView BIOMAGNETOMETER SYSTEM (2016), 0 descendants of its own
- K133419: Babymeg Biomagnetometer System (2014), 0 descendants of its own

## Indications for use
The Magnes 11 Biomagnetometer is intended for use in diagnostic procedures that require the measurement and display of exuacranial magnetic ficlds and information about the electrical activity of the brain as inferred from those fields.

Source page: https://510kreport.com/device/K941553
Methodology: https://510kreport.com/methodology