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FDA 510(k)

ECHELON RAPID CARDIAC COIL

K-Number: K110120 · 2011-02-25

ApplicantHitachi Medical Systems America, Inc.
Decision Date2011-02-25
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ECHELON RAPID CARDIAC COIL is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi Medical Systems America, Inc.. It received FDA 510(k) clearance on 2011-02-25 under 510(k) number K110120. 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 ECHELON RAPID CARDIAC COIL?

ECHELON RAPID CARDIAC COIL is a medical device that received FDA 510(k) clearance on 2011-02-25. The listed applicant is Hitachi Medical Systems America, Inc.. The 510(k) number is K110120.

When did ECHELON RAPID CARDIAC COIL receive FDA 510(k) clearance?

ECHELON RAPID CARDIAC COIL received FDA 510(k) clearance on 2011-02-25, under 510(k) number K110120.

Who is the listed applicant for ECHELON RAPID CARDIAC COIL?

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

What is the FDA product code for ECHELON RAPID CARDIAC COIL?

The FDA product code for ECHELON RAPID CARDIAC COIL is MOS.

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Other records listing Hitachi Medical Systems America, Inc. as applicant

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K163528HITACHI Supria Whole-body X-ray CT System Phase 3K162079TRILLIUM Oval Head Coil 32K161748SUPRIA w/guideShot OptionK160152Trillium Oval V 5.1 MRI SystemK153547ECHELON Oval V 5.1 MRI SystemK123509SCENARIA PHASE 2 WHOLE-BODY X-RAY CT SYSTEM

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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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