FDA.reportPublic FDA data

510(k) K244054

Device
16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247)
Applicant
Quality Electrodynamics
510(k) number
K244054
Product code
MOS
Decision
Substantially Equivalent (SESE)
Decision date
2025-02-28
Date received
2024-12-31
Regulation
892.1000
Classification name
Coil, Magnetic Resonance, Specialty
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JoVanna Boudreaux
Address
6655 Beta Dr. Suite 100 Mayfield Village OH US 44122 44122

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MOS#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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K253182InkSpace Imaging Small Body Array (SBA12PH30x)Inkspace Imaging, Inc.2025-10-20
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K243675InkSpace Imaging Small Body ArrayInkspace Imaging, Inc.2024-12-20
K243316XENOVIEW 3.0T Chest CoilPolarean, Inc.2024-11-19
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K243033dS Wrist coil 8ch 1.5TPhilips Medical Systems Nederland B.V.2024-10-18