Neonate Head and Body Coils

Q: What is the product code of K083541?

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

FDA 510(k) K083541 · Advanced Imaging Research, Inc.

Substantially Equivalent

510(k) numberK083541

Submission

Device name: Neonate Head and Body Coils
Applicant: Advanced Imaging Research, Inc.
Cleveland, OH, US
Received: November 28, 2008
Decision date: February 24, 2009
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

510(k)	Device	Applicant	Decision
K262330	dS 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
K262294	dS 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
K260947	0.55T 12Ch Breast CoilMOS · Special	Neocoil, LLC	04/23/2026SE
K252587	HD 8Ch Wrist ArrayMOS · Traditional	Shenzhen RF Tech Co., Ltd.	04/14/2026SE
K252876	GEM 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
K260519	Smart Fit TorsoCardiac 1.5TMOS · Special	Philips Healthcare (Suzhou) Co., Ltd.	03/20/2026SE
K252179	GEM 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
K253738	3.0T Air 32CH HnaMOS · Abbreviated	Ge Healthcare Coils (Usa Instruments, Inc.)	01/23/2026SE
K254190	dS 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
K253182	InkSpace Imaging Small Body Array (SBA12PH30x)MOS · Special	Inkspace Imaging, Inc.	10/20/2025SE

More from Inkspace Imaging, Inc.

510(k)	Device	Decision
K083539	Infant Cardiac ArrayMOS · Traditional	04/03/2009SE
K023929	Magnetic Resonance Diagnostic DeviceMOS · Traditional	02/21/2003SE

Questions and answers

When was Neonate Head and Body Coils cleared by the FDA?

Neonate Head and Body Coils (K083541) received a 510(k) decision of Substantially Equivalent on February 24, 2009, 88 days after the submission was received.

What is the product code of K083541?

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