Permanent Beacon Transponder, Soft Tissue Beacon Transponder, Beacon Care Package - Soft Tissue (17G)— 510(k) K152761

Substantially Equivalent

Varian Medical Systems, Inc.

FDA 510(k) clearance K152761 for Permanent Beacon Transponder, Soft Tissue Beacon Transponder, Beacon Care Package - Soft Tissue (17G), Substantially Equivalent on 2015-11-25. Applicant: Varian Medical Systems, Inc..

Clearance details

Applicant: Varian Medical Systems, Inc.
Product code: Code IYE
Advisory panel: Radiology
Date received: 2015-09-24
Decision date: 2015-11-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Seattle, WA, US

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Adverse events under product code IYE

product code IYE

Malfunction: 455
Other: 3
Total: 458

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.