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FDA 510(k)

MAMMOSOURCE HIGH DOSE RATE (HDR) REMOTE AFTERLOADER

K-Number: K040541 · 2004-03-22

ApplicantVarian Medical Systems, Inc.
Decision Date2004-03-22
Product CodeJAQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MAMMOSOURCE HIGH DOSE RATE (HDR) REMOTE AFTERLOADER 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 2004-03-22 under 510(k) number K040541. The device is classified under product code JAQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAMMOSOURCE HIGH DOSE RATE (HDR) REMOTE AFTERLOADER?

MAMMOSOURCE HIGH DOSE RATE (HDR) REMOTE AFTERLOADER is a medical device that received FDA 510(k) clearance on 2004-03-22. The listed applicant is Varian Medical Systems, Inc.. The 510(k) number is K040541.

When did MAMMOSOURCE HIGH DOSE RATE (HDR) REMOTE AFTERLOADER receive FDA 510(k) clearance?

MAMMOSOURCE HIGH DOSE RATE (HDR) REMOTE AFTERLOADER received FDA 510(k) clearance on 2004-03-22, under 510(k) number K040541.

Who is the listed applicant for MAMMOSOURCE HIGH DOSE RATE (HDR) REMOTE AFTERLOADER?

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 MAMMOSOURCE HIGH DOSE RATE (HDR) REMOTE AFTERLOADER?

The FDA product code for MAMMOSOURCE HIGH DOSE RATE (HDR) REMOTE AFTERLOADER is JAQ.

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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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