16 CH Multipurpose Coil Variety

FDA 510(k) K140252 · Noras Rontgen-Und Medizintechnik GmbH

Substantially Equivalent

510(k) numberK140252

Submission

Device name
16 CH Multipurpose Coil Variety
Applicant
Noras Rontgen-Und Medizintechnik GmbH
Höchberg, DE
Received
January 31, 2014
Decision date
May 8, 2014
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)DeviceApplicantDecision
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
K052987Breast Immobilization and Biopsy Device, Models Bi 160-O, Bi 160-PA and Bi 160-CCLNH · Special 11/08/2005SE

Questions and answers

When was 16 CH Multipurpose Coil Variety cleared by the FDA?

16 CH Multipurpose Coil Variety (K140252) received a 510(k) decision of Substantially Equivalent on May 8, 2014, 97 days after the submission was received.

What is the product code of K140252?

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