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FDA 510(k)

Surface Applicator Set

K-Number: K162018 · 2017-02-28

ApplicantVarian Medical Systems, Inc.
Decision Date2017-02-28
Product CodeJAQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Surface Applicator Set 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 2017-02-28 under 510(k) number K162018. 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 Surface Applicator Set?

Surface Applicator Set is a medical device that received FDA 510(k) clearance on 2017-02-28. The listed applicant is Varian Medical Systems, Inc.. The 510(k) number is K162018.

When did Surface Applicator Set receive FDA 510(k) clearance?

Surface Applicator Set received FDA 510(k) clearance on 2017-02-28, under 510(k) number K162018.

Who is the listed applicant for Surface Applicator Set?

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 Surface Applicator Set?

The FDA product code for Surface Applicator Set is JAQ.

Other records listing Varian Medical Systems, Inc. as applicant

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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.

K262383LumenCare AzureNucletron B.V.K252717MAASTRO Rectal Applicator SetVarian Medical SystemsK251037Rectal ApplicatorNucletron B.V.K252884Guided Aarhus Applicator SetVarian Medical SystemsK250299CT/ MR Tandem and Ovoid SetVarian Medical Systems, Inc.K250289Intracavitary/Interstitial SystemVarian Medical Systems

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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