Cleared Traditional

K182504 - 3.0T Air MP M

K182504 is the FDA 510(k) clearance for 3.0T Air MP M by Ge Healthcare Coils (Usa Instruments, Inc.). It is a Class 2 Radiology device (product code MOS) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K182504 · Ge Healthcare Coils (Usa Instruments, Inc.) · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2018
Decision
30d
Days
Class 2
Risk

K182504 is an FDA 510(k) clearance for the 3.0T Air MP M, 3.0T Air MP L. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Ge Healthcare Coils (Usa Instruments, Inc.) (Aurora, US). The FDA issued a Cleared decision on October 12, 2018 after a review of 30 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 Ge Healthcare Coils (Usa Instruments, Inc.) devices

Submission Details

510(k) Number K182504 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2018
Decision Date October 12, 2018
Days to Decision 30 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
77d faster than avg
Panel avg: 107d · This submission: 30d
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 298
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K182504.
1.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil
K181948 · Rapid Biomedical GmbH · Nov 2018
1.5T 16ch Breast Coil
K182958 · Neocoil, LLC · Nov 2018
1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA, 1.5T 30ch AIR AA
K182590 · Ge Healthcare · Oct 2018
16ch Foot/ Ankle SPEEDER
K181697 · Quality Electrodynamics, LLC · Jul 2018
48CH Head Coil
K180666 · Ge Healthcare Coils (Usa Instruments, Inc.) · Apr 2018
P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil
K163661 · Rapid Biomedical GmbH · Mar 2018