XENOVIEW 3.0T Chest Coil

Q: What is the product code of K243316?

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) K243316 · Polarean, Inc.

Substantially Equivalent

510(k) numberK243316

Submission

Device name: XENOVIEW 3.0T Chest Coil
Applicant: Polarean, Inc.
Durham, NC, US
Received: October 22, 2024
Decision date: November 19, 2024
Decision: Substantially Equivalent (SESE)
Type: Special 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
K231647	XENOVIEW 3.0T Chest CoilMOS · Special	06/29/2023SE
K223071	Xenoview VDPLLZ · Traditional	12/23/2022SE
K212239	XENOVIEW 3.0T Chest CoilMOS · Traditional	12/23/2022SE

Questions and answers

When was XENOVIEW 3.0T Chest Coil cleared by the FDA?

XENOVIEW 3.0T Chest Coil (K243316) received a 510(k) decision of Substantially Equivalent on November 19, 2024, 28 days after the submission was received.

What is the product code of K243316?

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