FDA 510(k)

MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM

K-Number: K033247 · 2003-11-05

Decision Date2003-11-05

Product CodeDXT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medrad, Inc.. It received FDA 510(k) clearance on 2003-11-05 under 510(k) number K033247. 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 SPECTRIS SOLARIS MR INJECTOR SYSTEM?

MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM is a medical device that received FDA 510(k) clearance on 2003-11-05. The listed applicant is Medrad, Inc.. The 510(k) number is K033247.

When did MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM receive FDA 510(k) clearance?

MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM received FDA 510(k) clearance on 2003-11-05, under 510(k) number K033247.

Who is the listed applicant for MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM?

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

What is the FDA product code for MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM?

The FDA product code for MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM is 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.