Cleared Traditional

K011608 - MODEL 235GE-64

Also marketed or referenced as:
MULTI PURPOSE FLEX ARRAY COIL

K011608 is the FDA 510(k) clearance for MODEL 235GE-64 by Medical Advances, Inc.. It is a Class 2 Radiology device (product code MOS) cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K011608 · Medical Advances, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
81d
Days
Class 2
Risk

K011608 is an FDA 510(k) clearance for the MODEL 235GE-64. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Medical Advances, Inc. (Milwaukee, US). The FDA issued a Cleared decision on August 14, 2001 after a review of 81 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 Medical Advances, Inc. devices

Submission Details

510(k) Number K011608 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 2001
Decision Date August 14, 2001
Days to Decision 81 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 107d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 311
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K011608.
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
HNC-127 NEUROVASCULAR ARRAY COIL
K012353 · Mri Devices Corp. · Aug 2001
MARK 9000 PHASED ARRAY SHOULDER COIL
K010946 · Usa Instruments, Inc. · May 2001
KFA-127 KNEE, FOOT AND ANKLE ARRAY
K003505 · Mri Devices Corp. · May 2001