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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 a medical device manufactured by Varian Medical Systems, Inc.. It received FDA 510(k) clearance on 2016-10-20 under approval 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. It is manufactured by Varian Medical Systems, Inc.. The 510(k) number is K161540.

When was Advanced Breast Template System approved by the FDA?

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

What company makes Advanced Breast Template System?

Advanced Breast Template System is manufactured by Varian Medical Systems, Inc..

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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Other Devices by Varian Medical Systems, Inc.

K162476Varian High Energy Linear Accelerator K160045Heyman Packing Applicator Set K161576Esophagus Bougie Set K160516Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Universal Cervix Probe Set, odd lengths, Universal Cervix Probe Set, even lengths K160021Varian Sterilization Boxes K162533Kelowna GYN and Crook Prostate Templates

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Related Devices (Code: JAQ)

K160045Heyman Packing Applicator SetVarian Medical Systems, Inc. K161576Esophagus Bougie SetVarian Medical Systems, Inc. K160516Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Universal Cervix Probe Set, odd lengths, Universal Cervix Probe Set, even lengthsVarian Medical Systems, Inc. K150979CT/MR Compatible M.A.C. Interstitial GYN TemplateMick Radio-Nuclear Instruments, Inc. K160021Varian Sterilization BoxesVarian Medical Systems, Inc. K162533Kelowna GYN and Crook Prostate TemplatesVarian Medical Systems, Inc.

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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