Cleared Traditional

K001097 - ACTIVE ARRAY CATHETER

K001097 is an FDA 510(k) clearance for ACTIVE ARRAY CATHETER, manufactured by Image-Guided Neurologics, Inc.. The device is a Class 2 Radiology device with product code MOS cleared through the Traditional 510(k) pathway after a 289-day FDA review.

K001097 · Image-Guided Neurologics, Inc. · Radiology device
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Jan 2001
Decision
289d
Days
Class 2
Risk

K001097 is an FDA 510(k) clearance for the ACTIVE ARRAY CATHETER, MODEL CS-2000. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Image-Guided Neurologics, Inc. (Melbourne, US). The FDA issued a Cleared decision on January 18, 2001 after a review of 289 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1000 - 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 Image-Guided Neurologics, Inc. devices

FDA 510(k) Submission Details - K001097

510(k) Number K001097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2000
Decision Date January 18, 2001
Days to Decision 289 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
182d slower than avg
Panel avg: 107d · This submission: 289d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MOS Device Classification - Class 2, Special Controls

Product Code MOS Coil, Magnetic Resonance, Specialty
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1000
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 - MOS Coil, Magnetic Resonance, Specialty

All 313
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K001097.
SIGNA SP 0.5T ROTATING HORIZONTAL BODY COIL
K003946 · GE Medical Systems · Feb 2001
HRH-127 HEAD ARRAY COIL
K010140 · Mri Devices Corp. · Feb 2001
PHS-63 PEDIATRIC HEAD AND SPINE ARRAY COIL
K003655 · Mri Devices Corp. · Feb 2001
MODEL 342GE-64 HIGH RESOLUTION BRAIN COIL
K003685 · Medical Advances, Inc. · Dec 2000
MODEL 205GE-64: PATHWAY MRI CAROTID ARRAY COIL
K003144 · Medical Advances, Inc. · Dec 2000
HRH-63 HEAD ARRAY COIL
K002774 · Mri Devices Corp. · Nov 2000