Cleared Traditional

16ch Flex SPEEDER Medium 1.5T (Q7000246) (K244054) - FDA 510(k) Clearance

Also marketed or referenced as:
16ch Flex SPEEDER Large 1.5T (Q7000247)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K244054 · Quality Electrodynamics · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2025
Decision
59d
Days
Class 2
Risk

K244054 is an FDA 510(k) clearance for the 16ch Flex SPEEDER Medium 1.5T (Q7000246). Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Quality Electrodynamics (Mayfield Village, US). The FDA issued a Cleared decision on February 28, 2025 after a review of 59 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 Quality Electrodynamics devices

Submission Details

510(k) Number K244054 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 2024
Decision Date February 28, 2025
Days to Decision 59 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
48d faster than avg
Panel avg: 107d · This submission: 59d
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 95
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K244054.
dS Base 1.5T
K254190 · Philips Medical Systems Nederland B.V. · Jan 2026
InkSpace Imaging Small Body Array (SBA12PH30x)
K253182 · Inkspace Imaging, Inc. · Oct 2025
e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector
K243428 · Dxtx Medical, Inc. · Jul 2025
InkSpace Imaging Small Body Array
K243675 · Inkspace Imaging, Inc. · Dec 2024
XENOVIEW 3.0T Chest Coil
K243316 · Polarean, Inc. · Nov 2024
dS Knee Coil 8ch 1.5T
K242879 · Philips Medical Systems Nederland B.V. · Oct 2024