Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Anchored Beacon(R) transponder, Anchored transponder, Beacon Care Package - Lung

K-Number: K170570 · 2018-04-06

Decision Date2018-04-06
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Anchored Beacon(R) transponder, Anchored transponder, Beacon Care Package - Lung 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 2018-04-06 under 510(k) number K170570. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Anchored Beacon(R) transponder, Anchored transponder, Beacon Care Package - Lung?

Anchored Beacon(R) transponder, Anchored transponder, Beacon Care Package - Lung is a medical device that received FDA 510(k) clearance on 2018-04-06. The listed applicant is Varian Medical Systems, Inc.. The 510(k) number is K170570.

When did Anchored Beacon(R) transponder, Anchored transponder, Beacon Care Package - Lung receive FDA 510(k) clearance?

Anchored Beacon(R) transponder, Anchored transponder, Beacon Care Package - Lung received FDA 510(k) clearance on 2018-04-06, under 510(k) number K170570.

Who is the listed applicant for Anchored Beacon(R) transponder, Anchored transponder, Beacon Care Package - Lung?

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 Anchored Beacon(R) transponder, Anchored transponder, Beacon Care Package - Lung?

The FDA product code for Anchored Beacon(R) transponder, Anchored transponder, Beacon Care Package - Lung is IYE.

Other records listing Varian Medical Systems, Inc. as applicant

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.

View all 96 devices →

Related Devices (Code: IYE)

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.

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.