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FDA 510(k)

3.0.T SIGNA VH/I (T/R) BODY IMAGING COIL

K-Number: K003613 · 2001-04-03

ApplicantGE Medical Systems
Decision Date2001-04-03
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

3.0.T SIGNA VH/I (T/R) BODY IMAGING COIL is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems. It received FDA 510(k) clearance on 2001-04-03 under 510(k) number K003613. 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 3.0.T SIGNA VH/I (T/R) BODY IMAGING COIL?

3.0.T SIGNA VH/I (T/R) BODY IMAGING COIL is a medical device that received FDA 510(k) clearance on 2001-04-03. The listed applicant is GE Medical Systems. The 510(k) number is K003613.

When did 3.0.T SIGNA VH/I (T/R) BODY IMAGING COIL receive FDA 510(k) clearance?

3.0.T SIGNA VH/I (T/R) BODY IMAGING COIL received FDA 510(k) clearance on 2001-04-03, under 510(k) number K003613.

Who is the listed applicant for 3.0.T SIGNA VH/I (T/R) BODY IMAGING COIL?

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

What is the FDA product code for 3.0.T SIGNA VH/I (T/R) BODY IMAGING COIL?

The FDA product code for 3.0.T SIGNA VH/I (T/R) BODY IMAGING COIL is MOS.

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Related Devices (Code: MOS)

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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, LLCK252587HD 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

View on FDA Database →

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

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