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FDA 510(k)

1.5T and 3.0T 16 CH GE Shoulder Coils

K-Number: K162001 · 2016-08-31

ApplicantInvivo Corporation
Decision Date2016-08-31
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

1.5T and 3.0T 16 CH GE Shoulder Coils is the device name listed in this FDA 510(k) record. The listed applicant is Invivo Corporation. It received FDA 510(k) clearance on 2016-08-31 under 510(k) number K162001. 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 1.5T and 3.0T 16 CH GE Shoulder Coils?

1.5T and 3.0T 16 CH GE Shoulder Coils is a medical device that received FDA 510(k) clearance on 2016-08-31. The listed applicant is Invivo Corporation. The 510(k) number is K162001.

When did 1.5T and 3.0T 16 CH GE Shoulder Coils receive FDA 510(k) clearance?

1.5T and 3.0T 16 CH GE Shoulder Coils received FDA 510(k) clearance on 2016-08-31, under 510(k) number K162001.

Who is the listed applicant for 1.5T and 3.0T 16 CH GE Shoulder Coils?

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

What is the FDA product code for 1.5T and 3.0T 16 CH GE Shoulder Coils?

The FDA product code for 1.5T and 3.0T 16 CH GE Shoulder Coils is MOS.

Other records listing Invivo Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K213766dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for 1.5T and 3.0T, ds Small Extremity 16Ch Coils for 1.5T and 3.0TK212227Philips MR Patient Care PortalK212175DynaCADK193403UroNav SystemK192200DynaCADK182561UroNav (Version 3.0)

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Related Devices (Code: MOS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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