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FDA 510(k)

GAMMAMEDPLUS IX SERIES HDR AFTERLOADER

K-Number: K071381 · 2007-07-18

ApplicantVarian Medical Systems
Decision Date2007-07-18
Product CodeJAQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GAMMAMEDPLUS IX SERIES HDR AFTERLOADER 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 2007-07-18 under 510(k) number K071381. 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 GAMMAMEDPLUS IX SERIES HDR AFTERLOADER?

GAMMAMEDPLUS IX SERIES HDR AFTERLOADER is a medical device that received FDA 510(k) clearance on 2007-07-18. The listed applicant is Varian Medical Systems. The 510(k) number is K071381.

When did GAMMAMEDPLUS IX SERIES HDR AFTERLOADER receive FDA 510(k) clearance?

GAMMAMEDPLUS IX SERIES HDR AFTERLOADER received FDA 510(k) clearance on 2007-07-18, under 510(k) number K071381.

Who is the listed applicant for GAMMAMEDPLUS IX SERIES HDR AFTERLOADER?

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 GAMMAMEDPLUS IX SERIES HDR AFTERLOADER?

The FDA product code for GAMMAMEDPLUS IX SERIES HDR AFTERLOADER is JAQ.

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Related Devices (Code: JAQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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