Cleared Traditional

K980477 - IMAGE VUE EEG

K980477 is an FDA 510(k) clearance for IMAGE VUE EEG, manufactured by Sam Technology, Inc.. The device is a Class 2 Neurology device with product code OLX cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K980477 · Sam Technology, Inc. · Neurology device
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Aug 1998
Decision
181d
Days
Class 2
Risk

K980477 is an FDA 510(k) clearance for the IMAGE VUE EEG. Classified as Source Localization Software For Electroencephalograph Or Magnetoencephalograph (product code OLX), Class II - Special Controls.

Submitted by Sam Technology, Inc. (Deerfield, US). The FDA issued a Cleared decision on August 6, 1998 after a review of 181 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 Sam Technology, Inc. devices

FDA 510(k) Submission Details - K980477

510(k) Number K980477 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1998
Decision Date August 06, 1998
Days to Decision 181 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
33d slower than avg
Panel avg: 148d · This submission: 181d
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 11
Devices cleared under the same product code (OLX) and FDA review panel - the closest regulatory comparables to K980477.
PreOp
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K993708 · Biomagnetic Technologies, Inc. · Dec 1999
NEUROMAG VECTORVIEW
K984401 · Philips Medical Systems (Cleveland), Inc. · Dec 1998
MAGNES II BIOMAGNETOMETER
K941553 · Biomagnetic Technologies, Inc. · May 1996