Cleared Traditional

TOSHIBA 3T 32CH HEAD SPEEDER COIL,

K122638 · Quality Electrodynamics · Radiology
Sep 2012
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K122638 is an FDA 510(k) clearance for the TOSHIBA 3T 32CH HEAD SPEEDER COIL,, a Coil, Magnetic Resonance, Specialty (Class II — Special Controls, product code MOS), submitted by Quality Electrodynamics (Mayfield Village, US). The FDA issued a Cleared decision on September 25, 2012, 27 days after receiving the submission on August 29, 2012. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K122638 FDA.gov
FDA Decision Cleared SESE
Date Received August 29, 2012
Decision Date September 25, 2012
Days to Decision 27 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code MOS — Coil, Magnetic Resonance, Specialty
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1000

Similar Devices — MOS Coil, Magnetic Resonance, Specialty

All 483
GEM Flex Coil 16-L Array, 1.5T Receive Only; GEM Flex Coil 16-M Array, 1.5T Receive Only; GEM Flex Coil 16-S Array, 1.5T Receive Only
K252179 · Shenzhen RF Tech Co., Ltd. · Feb 2026
3.0T AIR 32CH HNA
K253738 · Ge Healthcare Coils (Usa Instruments, Inc.) · Jan 2026
dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS HeadNeck 3.0T
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
16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247)
K244054 · Quality Electrodynamics · Feb 2025