# K962764: Neuromag-122

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems (Cleveland), Inc.
- Decided: Oct 31, 1996 after 107 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: 1 generation back to K901215 (1990). 1 ancestor in all.
20 later devices descend from it; 4 cite it directly.
0 of 22 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) Summary page 2.

## Most influential descendants
- K971329: CTF Systems Inc, Whole-Cortex Meg System (with Optional Eeg Subsystem) (1997), 12 descendants of its own
- K030737: Omega Whole-Cortex MFG System, Models Omega 151, Omega 275 (2003), 10 descendants of its own
- K041264: Elekta OY (2004), 8 descendants of its own
- K033488: Cmi Magnetocardiograph (2004), 5 descendants of its own
- K050035: Elekta Neuromag with Maxwell Filter (2005), 4 descendants of its own

## Indications for use
The Neuromag-122 system is intended for use as a magneto encephalographic (MEG) device which non-invasively detects and displays biomagnetic signals produced by electrically active nerve tissue in the brain. When interpreted by a trained clinician, the data enhances the diagnostic capability by providing useful information about the location relative to brain anatomy of active nerve tissue responsible for critical brain functions.

Source page: https://510kreport.com/device/K962764
Methodology: https://510kreport.com/methodology