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FDA 510(k)

1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support

K-Number: K191539 · 2020-01-31

ApplicantRapid Biomedical GmbH
Decision Date2020-01-31
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support is a medical device manufactured by Rapid Biomedical GmbH. It received FDA 510(k) clearance on 2020-01-31 under approval number K191539. 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 Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support?

1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support is a medical device that received FDA 510(k) clearance on 2020-01-31. It is manufactured by Rapid Biomedical GmbH. The 510(k) number is K191539.

When was 1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support approved by the FDA?

1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support received FDA 510(k) clearance on 2020-01-31, under approval number K191539.

What company makes 1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support?

1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support is manufactured by Rapid Biomedical GmbH.

What is the FDA product code for 1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support?

The FDA product code for 1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support is MOS.

Other Devices by Rapid Biomedical GmbH

K1819481.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil K163661P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil K21348031P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head Coil

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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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