Cleared Traditional

K001781 - CURRY MULTIMODAL NEUROIMAGING SOFTWARE

K001781 is an FDA 510(k) clearance for CURRY MULTIMODAL NEUROIMAGING SOFTWARE, manufactured by Neurosoft, Inc.. The device is a Class 2 Neurology device with product code OLX cleared through the Traditional 510(k) pathway after a 237-day FDA review.

K001781 · Neurosoft, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2001
Decision
237d
Days
Class 2
Risk

K001781 is an FDA 510(k) clearance for the CURRY MULTIMODAL NEUROIMAGING SOFTWARE. Classified as Source Localization Software For Electroencephalograph Or Magnetoencephalograph (product code OLX), Class II - Special Controls.

Submitted by Neurosoft, Inc. (El Paso, US). The FDA issued a Cleared decision on February 5, 2001 after a review of 237 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 Neurosoft, Inc. devices

FDA 510(k) Submission Details - K001781

510(k) Number K001781 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2000
Decision Date February 05, 2001
Days to Decision 237 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
89d slower than avg
Panel avg: 148d · This submission: 237d
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 12
Devices cleared under the same product code (OLX) and FDA review panel - the closest regulatory comparables to K001781.
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IMAGE VUE EEG
K980477 · Sam Technology, Inc. · Aug 1998