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FDA 510(k)

Advanced Breast Template System

K-Number: K161540 · 2016-10-20

ApplicantVarian Medical Systems, Inc.
Decision Date2016-10-20
Product CodeJAQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Advanced Breast Template System 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 2016-10-20 under 510(k) number K161540. 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 Advanced Breast Template System?

Advanced Breast Template System is a medical device that received FDA 510(k) clearance on 2016-10-20. The listed applicant is Varian Medical Systems, Inc.. The 510(k) number is K161540.

When did Advanced Breast Template System receive FDA 510(k) clearance?

Advanced Breast Template System received FDA 510(k) clearance on 2016-10-20, under 510(k) number K161540.

Who is the listed applicant for Advanced Breast Template System?

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 Advanced Breast Template System?

The FDA product code for Advanced Breast Template System 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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