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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 a medical device manufactured by Rapid Biomedical GmbH. It received FDA 510(k) clearance on 2018-11-16 under approval 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. It is manufactured by Rapid Biomedical GmbH. The 510(k) number is K181948.

When was 1.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil approved by the FDA?

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

What company makes 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 manufactured by Rapid Biomedical GmbH.

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.

Related Clinical Trials

NCT07562789 Role of PCGEM1 in Breast Cancer NOT_YET_RECRUITING NCT06268405 Positron Emission Mammography and Liquid Biopsy in Women With High-risk Breast Screenings RECRUITING NCT07505797 ATUSA Ultrasound Diagnostic Imaging for Breast Lesions Evaluation (AUDIBLE) RECRUITING

Other Devices by Rapid Biomedical GmbH

K163661P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil K1915391.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support 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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