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FDA 510(k)

INTEGRATED COLLIMATOR VERIFICATION AND INTERLOCK SYSTEM (ICVI)

K-Number: K123788 · 2013-01-15

ApplicantVarian Medical Systems, Inc.
Decision Date2013-01-15
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

INTEGRATED COLLIMATOR VERIFICATION AND INTERLOCK SYSTEM (ICVI) 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 2013-01-15 under 510(k) number K123788. 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 INTEGRATED COLLIMATOR VERIFICATION AND INTERLOCK SYSTEM (ICVI)?

INTEGRATED COLLIMATOR VERIFICATION AND INTERLOCK SYSTEM (ICVI) is a medical device that received FDA 510(k) clearance on 2013-01-15. The listed applicant is Varian Medical Systems, Inc.. The 510(k) number is K123788.

When did INTEGRATED COLLIMATOR VERIFICATION AND INTERLOCK SYSTEM (ICVI) receive FDA 510(k) clearance?

INTEGRATED COLLIMATOR VERIFICATION AND INTERLOCK SYSTEM (ICVI) received FDA 510(k) clearance on 2013-01-15, under 510(k) number K123788.

Who is the listed applicant for INTEGRATED COLLIMATOR VERIFICATION AND INTERLOCK SYSTEM (ICVI)?

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 INTEGRATED COLLIMATOR VERIFICATION AND INTERLOCK SYSTEM (ICVI)?

The FDA product code for INTEGRATED COLLIMATOR VERIFICATION AND INTERLOCK SYSTEM (ICVI) 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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