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FDA 510(k)

1.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil

K-Number: K181948 · 2018-11-16

ApplicantRapid Biomedical GmbH
Decision Date2018-11-16
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

1.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil is the device name listed in this FDA 510(k) record. The listed applicant is Rapid Biomedical GmbH. It received FDA 510(k) clearance on 2018-11-16 under 510(k) number K181948. 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 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil?

1.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil is a medical device that received FDA 510(k) clearance on 2018-11-16. The listed applicant is Rapid Biomedical GmbH. The 510(k) number is K181948.

When did 1.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil receive FDA 510(k) clearance?

1.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil received FDA 510(k) clearance on 2018-11-16, under 510(k) number K181948.

Who is the listed applicant for 1.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil?

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

What is the FDA product code for 1.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil?

The FDA product code for 1.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil is MOS.

Other records listing Rapid Biomedical GmbH 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.

K21348031P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head CoilK1915391.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil SupportK163661P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil

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

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

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