FDA 510(k)

MEDRAD SPECTRIS SOLARIS EP MR INJECTOR SYSTEM

K-Number: K042784 · 2004-12-10

Decision Date2004-12-10

Product CodeDXT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MEDRAD SPECTRIS SOLARIS EP 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 2004-12-10 under 510(k) number K042784. 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 EP MR INJECTOR SYSTEM?

MEDRAD SPECTRIS SOLARIS EP MR INJECTOR SYSTEM is a medical device that received FDA 510(k) clearance on 2004-12-10. The listed applicant is Medrad, Inc.. The 510(k) number is K042784.

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

MEDRAD SPECTRIS SOLARIS EP MR INJECTOR SYSTEM received FDA 510(k) clearance on 2004-12-10, under 510(k) number K042784.

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

The FDA product code for MEDRAD SPECTRIS SOLARIS EP 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.