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FDA 510(k)

TRILOGY WITH EXTERNAL SYSTEM GATING INTERFACE

K-Number: K081188 · 2008-07-14

ApplicantVarian Medical Systems, Inc.
Decision Date2008-07-14
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TRILOGY WITH EXTERNAL SYSTEM GATING INTERFACE is the device name listed in this FDA 510(k) record. The listed applicant is Varian Medical Systems, Inc.. It received FDA 510(k) clearance on 2008-07-14 under 510(k) number K081188. 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 TRILOGY WITH EXTERNAL SYSTEM GATING INTERFACE?

TRILOGY WITH EXTERNAL SYSTEM GATING INTERFACE is a medical device that received FDA 510(k) clearance on 2008-07-14. The listed applicant is Varian Medical Systems, Inc.. The 510(k) number is K081188.

When did TRILOGY WITH EXTERNAL SYSTEM GATING INTERFACE receive FDA 510(k) clearance?

TRILOGY WITH EXTERNAL SYSTEM GATING INTERFACE received FDA 510(k) clearance on 2008-07-14, under 510(k) number K081188.

Who is the listed applicant for TRILOGY WITH EXTERNAL SYSTEM GATING INTERFACE?

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

What is the FDA product code for TRILOGY WITH EXTERNAL SYSTEM GATING INTERFACE?

The FDA product code for TRILOGY WITH EXTERNAL SYSTEM GATING INTERFACE is IYE.

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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.

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