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FDA 510(k)

MILLENNIUM MULTI-LEAF COLLIMATOR

K-Number: K050442 · 2005-03-23

ApplicantVarian Medical Systems
Decision Date2005-03-23
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MILLENNIUM MULTI-LEAF COLLIMATOR is the device name listed in this FDA 510(k) record. The listed applicant is Varian Medical Systems. It received FDA 510(k) clearance on 2005-03-23 under 510(k) number K050442. 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 MILLENNIUM MULTI-LEAF COLLIMATOR?

MILLENNIUM MULTI-LEAF COLLIMATOR is a medical device that received FDA 510(k) clearance on 2005-03-23. The listed applicant is Varian Medical Systems. The 510(k) number is K050442.

When did MILLENNIUM MULTI-LEAF COLLIMATOR receive FDA 510(k) clearance?

MILLENNIUM MULTI-LEAF COLLIMATOR received FDA 510(k) clearance on 2005-03-23, under 510(k) number K050442.

Who is the listed applicant for MILLENNIUM MULTI-LEAF COLLIMATOR?

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

What is the FDA product code for MILLENNIUM MULTI-LEAF COLLIMATOR?

The FDA product code for MILLENNIUM MULTI-LEAF COLLIMATOR 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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