FDA 510(k)

MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit

K-Number: K182276 · 2018-11-01

Decision Date2018-11-01

Product CodeDXT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Medical Care, Inc.. It received FDA 510(k) clearance on 2018-11-01 under 510(k) number K182276. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit?

MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit is a medical device that received FDA 510(k) clearance on 2018-11-01. The listed applicant is Bayer Medical Care, Inc.. The 510(k) number is K182276.

When did MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit receive FDA 510(k) clearance?

MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit received FDA 510(k) clearance on 2018-11-01, under 510(k) number K182276.

Who is the listed applicant for MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit?

The FDA 510(k) record lists Bayer Medical Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit?

The FDA product code for MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit is DXT.

Other records listing Bayer Medical Care, Inc. as applicant

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Related Devices (Code: DXT)

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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.