Cleared Traditional

K200477 - Flex Body Speeder

K200477 is the FDA 510(k) clearance for Flex Body Speeder by Quality Electrodynamics, LLC. It is a Class 2 Radiology device (product code MOS) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K200477 · Quality Electrodynamics, LLC · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2020
Decision
41d
Days
Class 2
Risk

K200477 is an FDA 510(k) clearance for the Flex Body Speeder. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Quality Electrodynamics, LLC (Mayfield Heights, US). The FDA issued a Cleared decision on April 8, 2020 after a review of 41 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, LLC devices

Submission Details

510(k) Number K200477 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2020
Decision Date April 08, 2020
Days to Decision 41 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
66d faster than avg
Panel avg: 107d · This submission: 41d
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 K200477.
ds Head 32ch 3.0T
K213351 · Invivo Corporation (Business Trade Name: Philips) · Oct 2021
8ch Flex Suite
K200836 · Shenzhen RF Tech Co., Ltd. · Jul 2020
1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil
K201101 · Neocoil, LLC · Jun 2020
1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support
K191539 · Rapid Biomedical GmbH · Jan 2020
Flex Body SPEEDER
K193140 · Quality Electrodynamics, LLC · Jan 2020
Encompass 15 Channel Head Coil, 3T
K190668 · Qfix · Sep 2019