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FDA 510(k)

31P/1H HEAD COIL 3T; 23NA/1H HEAD COIL 3T; 13C/1H HEAD COIL 3T

K-Number: K102748 · 2011-05-13

ApplicantRapid Biomedical GmbH
Decision Date2011-05-13
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

31P/1H HEAD COIL 3T; 23NA/1H HEAD COIL 3T; 13C/1H HEAD COIL 3T 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 2011-05-13 under 510(k) number K102748. 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 31P/1H HEAD COIL 3T; 23NA/1H HEAD COIL 3T; 13C/1H HEAD COIL 3T?

31P/1H HEAD COIL 3T; 23NA/1H HEAD COIL 3T; 13C/1H HEAD COIL 3T is a medical device that received FDA 510(k) clearance on 2011-05-13. The listed applicant is Rapid Biomedical GmbH. The 510(k) number is K102748.

When did 31P/1H HEAD COIL 3T; 23NA/1H HEAD COIL 3T; 13C/1H HEAD COIL 3T receive FDA 510(k) clearance?

31P/1H HEAD COIL 3T; 23NA/1H HEAD COIL 3T; 13C/1H HEAD COIL 3T received FDA 510(k) clearance on 2011-05-13, under 510(k) number K102748.

Who is the listed applicant for 31P/1H HEAD COIL 3T; 23NA/1H HEAD COIL 3T; 13C/1H HEAD COIL 3T?

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 31P/1H HEAD COIL 3T; 23NA/1H HEAD COIL 3T; 13C/1H HEAD COIL 3T?

The FDA product code for 31P/1H HEAD COIL 3T; 23NA/1H HEAD COIL 3T; 13C/1H HEAD COIL 3T 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 SupportK1819481.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast CoilK163661P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex CoilK10234831P/1H DUAL TUNED SURFACE COIL 3T; 23NA/ 1H DUAL TURNED SURFACE COIL 3T; 13C /1H DUAL TURNED SURFACE COIL 3TK08325516CH AI BREAST COILS 1.5 T AND 3 T

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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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