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FDA 510(k)

ELEKTA SYNERGY; ELEKTA SYNERGY S AND XVIR3.5

K-Number: K051932 · 2005-08-12

ApplicantElekta, Inc.
Decision Date2005-08-12
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ELEKTA SYNERGY; ELEKTA SYNERGY S AND XVIR3.5 is the device name listed in this FDA 510(k) record. The listed applicant is Elekta, Inc.. It received FDA 510(k) clearance on 2005-08-12 under 510(k) number K051932. 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 ELEKTA SYNERGY; ELEKTA SYNERGY S AND XVIR3.5?

ELEKTA SYNERGY; ELEKTA SYNERGY S AND XVIR3.5 is a medical device that received FDA 510(k) clearance on 2005-08-12. The listed applicant is Elekta, Inc.. The 510(k) number is K051932.

When did ELEKTA SYNERGY; ELEKTA SYNERGY S AND XVIR3.5 receive FDA 510(k) clearance?

ELEKTA SYNERGY; ELEKTA SYNERGY S AND XVIR3.5 received FDA 510(k) clearance on 2005-08-12, under 510(k) number K051932.

Who is the listed applicant for ELEKTA SYNERGY; ELEKTA SYNERGY S AND XVIR3.5?

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

What is the FDA product code for ELEKTA SYNERGY; ELEKTA SYNERGY S AND XVIR3.5?

The FDA product code for ELEKTA SYNERGY; ELEKTA SYNERGY S AND XVIR3.5 is IYE.

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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.

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