FDA 510(k)

TANSMIT/RECEIVE QUADRATURE BODY COIL 3.0T

K-Number: K013894 · 2002-01-18

ApplicantPhilips Medical Systems North America, Inc.

Decision Date2002-01-18

Product CodeMOS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

TANSMIT/RECEIVE QUADRATURE BODY COIL 3.0T is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems North America, Inc.. It received FDA 510(k) clearance on 2002-01-18 under 510(k) number K013894. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TANSMIT/RECEIVE QUADRATURE BODY COIL 3.0T?

TANSMIT/RECEIVE QUADRATURE BODY COIL 3.0T is a medical device that received FDA 510(k) clearance on 2002-01-18. The listed applicant is Philips Medical Systems North America, Inc.. The 510(k) number is K013894.

When did TANSMIT/RECEIVE QUADRATURE BODY COIL 3.0T receive FDA 510(k) clearance?

TANSMIT/RECEIVE QUADRATURE BODY COIL 3.0T received FDA 510(k) clearance on 2002-01-18, under 510(k) number K013894.

Who is the listed applicant for TANSMIT/RECEIVE QUADRATURE BODY COIL 3.0T?

The FDA 510(k) record lists Philips Medical Systems North America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TANSMIT/RECEIVE QUADRATURE BODY COIL 3.0T?

The FDA product code for TANSMIT/RECEIVE QUADRATURE BODY COIL 3.0T is MOS.

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Other records listing Philips Medical Systems North America, Inc. as applicant

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Related Devices (Code: MOS)

K262330dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0TPhilips Medical Systems Nederland B.V.K262294dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes Hand/Wrist 16CH 3.0T;dS Small Extremity 16Ch 1.5T;dS Small Extremity 16Ch 3.0TPhilips Medical Systems Nederland B.V.K2609470.55T 12Ch Breast CoilNeocoil, LLC K252587HD 8Ch Wrist ArrayShenzhen RF Tech Co., Ltd.K252876GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Receive Only; GEM Flex Coil 16-S Array, 3.0T Receive OnlyShenzhen RF Tech Co., Ltd.K260519Smart Fit TorsoCardiac 1.5TPhilips Healthcare (Suzhou) Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.