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FDA 510(k)

ON-BOARD IMAGER DEVICE

K-Number: K042720 · 2004-10-29

ApplicantVarian Medical Systems
Decision Date2004-10-29
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ON-BOARD IMAGER DEVICE 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 2004-10-29 under 510(k) number K042720. 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 ON-BOARD IMAGER DEVICE?

ON-BOARD IMAGER DEVICE is a medical device that received FDA 510(k) clearance on 2004-10-29. The listed applicant is Varian Medical Systems. The 510(k) number is K042720.

When did ON-BOARD IMAGER DEVICE receive FDA 510(k) clearance?

ON-BOARD IMAGER DEVICE received FDA 510(k) clearance on 2004-10-29, under 510(k) number K042720.

Who is the listed applicant for ON-BOARD IMAGER DEVICE?

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 ON-BOARD IMAGER DEVICE?

The FDA product code for ON-BOARD IMAGER DEVICE 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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