Magnetic Resonance Diagnostic Device

FDA 510(k) K023929 · Advanced Imaging Research, Inc.

Substantially Equivalent

510(k) numberK023929

Submission

Device name
Magnetic Resonance Diagnostic Device
Applicant
Advanced Imaging Research, Inc.
Cleveland, OH, US
Received
November 25, 2002
Decision date
February 21, 2003
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MOS – Coil, Magnetic Resonance, Specialty
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1000
Specialty
Radiology

Other 510(k)s with product code MOS

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K262330dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil…MOS · Special Philips Medical Systems Nederland B.V.07/30/2026SE
K262294dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes…MOS · Special Philips Medical Systems Nederland B.V.07/24/2026SE
K2609470.55T 12Ch Breast CoilMOS · Special Neocoil, LLC04/23/2026SE
K252587HD 8Ch Wrist ArrayMOS · Traditional Shenzhen RF Tech Co., Ltd.04/14/2026SE
K252876GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Receive…MOS · Traditional Shenzhen RF Tech Co., Ltd.04/01/2026SE
K260519Smart Fit TorsoCardiac 1.5TMOS · Special Philips Healthcare (Suzhou) Co., Ltd.03/20/2026SE
K252179GEM Flex Coil 16-L Array, 1.5T Receive Only; GEM Flex Coil 16-M Array, 1.5T Receive…MOS · Traditional Shenzhen RF Tech Co., Ltd.02/10/2026SE
K2537383.0T Air 32CH HnaMOS · Abbreviated Ge Healthcare Coils (Usa Instruments, Inc.)01/23/2026SE
K254190dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS HeadNeck 3.0TMOS · Special Philips Medical Systems Nederland B.V.01/14/2026SE
K253182InkSpace Imaging Small Body Array (SBA12PH30x)MOS · Special Inkspace Imaging, Inc.10/20/2025SE

More from Inkspace Imaging, Inc.

510(k)DeviceDecision
K083539Infant Cardiac ArrayMOS · Traditional 04/03/2009SE
K083541Neonate Head and Body CoilsMOS · Traditional 02/24/2009SE

Questions and answers

When was Magnetic Resonance Diagnostic Device cleared by the FDA?

Magnetic Resonance Diagnostic Device (K023929) received a 510(k) decision of Substantially Equivalent on February 21, 2003, 88 days after the submission was received.

What is the product code of K023929?

The FDA product code is MOS – Coil, Magnetic Resonance, Specialty, a Class II (moderate risk) device regulated under 21 CFR 892.1000.