FDA 510(k)

XVI R4.5

K-Number: K100115 · 2010-03-10

Decision Date2010-03-10

Product CodeIYE

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

XVI R4.5 is the device name listed in this FDA 510(k) record. The listed applicant is Elekta , Ltd.. It received FDA 510(k) clearance on 2010-03-10 under 510(k) number K100115. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XVI R4.5?

XVI R4.5 is a medical device that received FDA 510(k) clearance on 2010-03-10. The listed applicant is Elekta , Ltd.. The 510(k) number is K100115.

When did XVI R4.5 receive FDA 510(k) clearance?

XVI R4.5 received FDA 510(k) clearance on 2010-03-10, under 510(k) number K100115.

Who is the listed applicant for XVI R4.5?

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

What is the FDA product code for XVI R4.5?

The FDA product code for XVI R4.5 is IYE.

Other records listing Elekta , Ltd. as applicant

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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.