Cleared Traditional

K152184 - MagView BIOMAGNETOMETER SYSTEM

K152184 is an FDA 510(k) clearance for MagView BIOMAGNETOMETER SYSTEM, manufactured by Tristan Technologies, Inc.. The device is a Class 2 Neurology device with product code OLY cleared through the Traditional 510(k) pathway after a 247-day FDA review.

K152184 · Tristan Technologies, Inc. · Neurology device
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Optimized for regulatory review, auditing and printing
Apr 2016
Decision
247d
Days
Class 2
Risk

K152184 is an FDA 510(k) clearance for the MagView BIOMAGNETOMETER SYSTEM. Classified as Magnetoencephalograph (product code OLY), Class II - Special Controls.

Submitted by Tristan Technologies, Inc. (San Diego, US). The FDA issued a Cleared decision on April 8, 2016 after a review of 247 days - an extended review cycle.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Tristan Technologies, Inc. devices

FDA 510(k) Submission Details - K152184

510(k) Number K152184 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2015
Decision Date April 08, 2016
Days to Decision 247 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d slower than avg
Panel avg: 148d · This submission: 247d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OLY Device Classification - Class 2, Special Controls

Product Code OLY Magnetoencephalograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Acquire, Display, Store, And Archive Biomagnetic Signals Produced By Electrically Active Nerve Tissue In The Brain To Provide Information About The Location Of Active Nerve Tissue Responsible For Certain Brain Functions Relative To Brain Anatomy.
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.