Cleared Traditional

K061639 - ECLIPSE TCD NEUROVASCULAR WORKSTATION

Also marketed or referenced as:
ELCLIPSE NEUROLOGICAL WORKSTATION WITH TCD AND VASCULAR DOPPLER CARDIOMON

K061639 is an FDA 510(k) clearance for ECLIPSE TCD NEUROVASCULAR WORKSTATION, manufactured by Axon Systems, Inc.. The device is a Class 2 Radiology device with product code GWF cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K061639 · Axon Systems, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2006
Decision
142d
Days
Class 2
Risk

K061639 is an FDA 510(k) clearance for the ECLIPSE TCD NEUROVASCULAR WORKSTATION. Classified as Stimulator, Electrical, Evoked Response (product code GWF), Class II - Special Controls.

Submitted by Axon Systems, Inc. (Hauppauge, US). The FDA issued a Cleared decision on November 1, 2006 after a review of 142 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 882.1870 - the FDA radiology and imaging software oversight 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 Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Axon Systems, Inc. devices

FDA 510(k) Submission Details - K061639

510(k) Number K061639 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2006
Decision Date November 01, 2006
Days to Decision 142 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 107d · This submission: 142d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWF Device Classification - Class 2, Special Controls

Product Code GWF Stimulator, Electrical, Evoked Response
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1870
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 Radiology devices follow this clearance model.

Regulatory Peers - GWF Stimulator, Electrical, Evoked Response

All 55
Devices cleared under the same product code (GWF) and FDA review panel - the closest regulatory comparables to K061639.
SEN-4100 ELECTRIC STIMULATOR
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NEUROVISION JJB SYSTEM
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MODIFICATION TO NUVASIVE NEUROVISION JJB SYSTEM
K062765 · Nuvasive, Inc. · Jan 2007
MEE-1000A NEUROMASTER
K051178 · Nihon Kohden America, Inc. · Aug 2005
MODIFICATION TO: NUVASIVE NEUROVISION JJB SYSTEM
K051384 · Nuvasive, Inc. · Jul 2005
TES-1 CONSTANT VOLTAGE ELECTRICAL STIMULATOR
K042350 · Cadwell Laboratories, Inc. · Nov 2004