Cleared Special

K040122 - MAYO CLINIC BC-10 3.0T

K040122 is an FDA 510(k) clearance for MAYO CLINIC BC-10 3.0T, manufactured by Mayo Clinic. The device is a Class 2 Radiology device with product code MOS cleared through the Special 510(k) pathway after a 85-day FDA review.

K040122 · Mayo Clinic · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2004
Decision
85d
Days
Class 2
Risk

K040122 is an FDA 510(k) clearance for the MAYO CLINIC BC-10 3.0T. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Mayo Clinic (Rochester, US). The FDA issued a Cleared decision on April 14, 2004 after a review of 85 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K040122

510(k) Number K040122 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 2004
Decision Date April 14, 2004
Days to Decision 85 days
Submission Type Special
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
22d faster than avg
Panel avg: 107d · This submission: 85d
Pathway characteristics
Modification to existing cleared device.

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 489
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K040122.
MODIFICATION TO E-SCAN XQ MRI SYSTEM
K041145 · Esaote, S.P.A. · May 2004
TORSO ARRAY COIL, MODEL 558GE-64
K041185 · Igc-Medical Advances, Inc. · May 2004
TEM 3000 HEAD COIL
K040937 · Mr Instruments, Inc. · Apr 2004
MODEL 475 - 8 CHANNEL T/R PHASED ARRAY LOWER EXTREMITY COIL
K040640 · Igc-Medical Advances, Inc. · Mar 2004
MODIFICATION TO HNC-127-INT NEUROVASCULAR ARRAY COIL
K040348 · Mri Devices Corp. · Mar 2004
MODIFICATION TO HRW-127 WRIST ARRAY COIL
K040349 · Mri Devices Corp. · Mar 2004
K040122 · MAYO CLINIC BC-10 3.0T
Download PDF FDA Summary Mayo Clinic