FDA 510(k)

OASIS RAPID BREAST COIL, MODEL MR-IBC-120 AND OASIS RAPID NV COIL, MODEL MR-NVC-120

K-Number: K080062 · 2008-02-11

ApplicantHitachi Medical Systems America, Inc.

Decision Date2008-02-11

Product CodeMOS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

OASIS RAPID BREAST COIL, MODEL MR-IBC-120 AND OASIS RAPID NV COIL, MODEL MR-NVC-120 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 2008-02-11 under 510(k) number K080062. 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 OASIS RAPID BREAST COIL, MODEL MR-IBC-120 AND OASIS RAPID NV COIL, MODEL MR-NVC-120?

OASIS RAPID BREAST COIL, MODEL MR-IBC-120 AND OASIS RAPID NV COIL, MODEL MR-NVC-120 is a medical device that received FDA 510(k) clearance on 2008-02-11. The listed applicant is Hitachi Medical Systems America, Inc.. The 510(k) number is K080062.

When did OASIS RAPID BREAST COIL, MODEL MR-IBC-120 AND OASIS RAPID NV COIL, MODEL MR-NVC-120 receive FDA 510(k) clearance?

OASIS RAPID BREAST COIL, MODEL MR-IBC-120 AND OASIS RAPID NV COIL, MODEL MR-NVC-120 received FDA 510(k) clearance on 2008-02-11, under 510(k) number K080062.

Who is the listed applicant for OASIS RAPID BREAST COIL, MODEL MR-IBC-120 AND OASIS RAPID NV COIL, MODEL MR-NVC-120?

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 OASIS RAPID BREAST COIL, MODEL MR-IBC-120 AND OASIS RAPID NV COIL, MODEL MR-NVC-120?

The FDA product code for OASIS RAPID BREAST COIL, MODEL MR-IBC-120 AND OASIS RAPID NV COIL, MODEL MR-NVC-120 is MOS.

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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.