Cleared Traditional

K941553 - MAGNES II BIOMAGNETOMETER

K941553 is an FDA 510(k) clearance for MAGNES II BIOMAGNETOMETER, manufactured by Biomagnetic Technologies, Inc.. The device is a Class 2 Neurology device with product code OLX cleared through the Traditional 510(k) pathway after a 778-day FDA review.

K941553 · Biomagnetic Technologies, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 1996
Decision
778d
Days
Class 2
Risk

K941553 is an FDA 510(k) clearance for the MAGNES II BIOMAGNETOMETER. Classified as Source Localization Software For Electroencephalograph Or Magnetoencephalograph (product code OLX), Class II - Special Controls.

Submitted by Biomagnetic Technologies, Inc. (San Diego, US). The FDA issued a Cleared decision on May 16, 1996 after a review of 778 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1400 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

FDA 510(k) Submission Details - K941553

510(k) Number K941553 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1994
Decision Date May 16, 1996
Days to Decision 778 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
629d slower than avg
Panel avg: 149d · This submission: 778d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OLX Device Classification - Class 2, Special Controls

Product Code OLX Source Localization Software For Electroencephalograph Or Magnetoencephalograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Correlation Of Electrical Activity Of The Brain Using Various Neuroimaging Modalities For Source-localization
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - OLX Source Localization Software For Electroencephalograph Or Magnetoencephalograph

All 24
Devices cleared under the same product code (OLX) and FDA review panel - the closest regulatory comparables to K941553.
BIOMAGNETIC TECHNOLOGIES MAGNES 3600 WHOLE HEAD MEG
K993708 · Biomagnetic Technologies, Inc. · Dec 1999
NEUROMAG VECTORVIEW
K984401 · Philips Medical Systems (Cleveland), Inc. · Dec 1998
IMAGE VUE EEG
K980477 · Sam Technology, Inc. · Aug 1998
700 SERIES BIOMAGNETOMETER
K901215 · Biomagnetic Technologies, Inc. · Jun 1990
K941553 · MAGNES II BIOMAGNETOMETER
Download PDF FDA Summary Biomagnetic Technolog…