FDA 510(k)

GE 3.0T GENERAL PURPOSE FLEX COIL

K-Number: K030953 · 2003-04-10

Decision Date2003-04-10

Product CodeMOS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

GE 3.0T GENERAL PURPOSE FLEX COIL is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems, Inc.. It received FDA 510(k) clearance on 2003-04-10 under 510(k) number K030953. 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 GE 3.0T GENERAL PURPOSE FLEX COIL?

GE 3.0T GENERAL PURPOSE FLEX COIL is a medical device that received FDA 510(k) clearance on 2003-04-10. The listed applicant is Ge Medical Systems, Inc.. The 510(k) number is K030953.

When did GE 3.0T GENERAL PURPOSE FLEX COIL receive FDA 510(k) clearance?

GE 3.0T GENERAL PURPOSE FLEX COIL received FDA 510(k) clearance on 2003-04-10, under 510(k) number K030953.

Who is the listed applicant for GE 3.0T GENERAL PURPOSE FLEX COIL?

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

What is the FDA product code for GE 3.0T GENERAL PURPOSE FLEX COIL?

The FDA product code for GE 3.0T GENERAL PURPOSE FLEX COIL is MOS.

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Other records listing Ge Medical Systems, 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.