Cleared Traditional

K012491 - MACHNET CAROTIDS COIL ARRAY ASSEMBLY

K012491 is an FDA 510(k) clearance for MACHNET CAROTIDS COIL ARRAY ASSEMBLY, manufactured by Machnet BV. The device is a Class 2 Radiology device with product code MOS cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K012491 · Machnet BV · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2001
Decision
82d
Days
Class 2
Risk

K012491 is an FDA 510(k) clearance for the MACHNET CAROTIDS COIL ARRAY ASSEMBLY. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Machnet BV (Deer Field, US). The FDA issued a Cleared decision on October 24, 2001 after a review of 82 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Machnet BV devices

FDA 510(k) Submission Details - K012491

510(k) Number K012491 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2001
Decision Date October 24, 2001
Days to Decision 82 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
25d faster than avg
Panel avg: 107d · This submission: 82d
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 386
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K012491.
CARDIOVASCULAR ARRAY
K013810 · W.L. Gore & Associates, Inc. · Nov 2001
HRH-127-ALLEGRA HEAD ARRAY COIL
K013508 · Mri Devices Corp. · Nov 2001
HNC-63-INT NEUROVASCULAR ARRAY COIL
K013602 · Mri Devices Corp. · Nov 2001
HRH-63-8 HEAD ARRAY COIL
K013159 · Mri Devices Corp. · Oct 2001
HAC-420 HEAD ARRAY COIL
K013322 · Mri Devices Corp. · Oct 2001
MODIFICATION TO: QWH-420 WRIST ARRAY COIL
K013099 · Mri Devices Corp. · Sep 2001