1.5T 4CH Large Flex Coil, 1.5 4CH Small Flex Coil

FDA 510(k) K123681 · Wipro GE Healthcare Private, Ltd.

Substantially Equivalent

510(k) numberK123681

Submission

Device name
1.5T 4CH Large Flex Coil, 1.5 4CH Small Flex Coil
Applicant
Wipro GE Healthcare Private, Ltd.
Bangalore, IN
Received
November 30, 2012
Decision date
February 22, 2013
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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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

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Questions and answers

When was 1.5T 4CH Large Flex Coil, 1.5 4CH Small Flex Coil cleared by the FDA?

1.5T 4CH Large Flex Coil, 1.5 4CH Small Flex Coil (K123681) received a 510(k) decision of Substantially Equivalent on February 22, 2013, 84 days after the submission was received.

What is the product code of K123681?

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