Anchored Beacon transponder, Beacon Care Package - Lung
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K170570 FDA 510(k)
- FDA Product Code
- IYE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.5050 FDA 510(k)
- Regulation Number
- 892.5050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Anchored Beacon transponder is a medical device designed to be permanently implanted in the lung. It serves as a fiducial marker for tracking and positioning during radiation therapy procedures.
This device is supplied as part of the Beacon Care Package - Lung and is intended for single-use. It has FDA 510(k) clearance with the product code IYE and is classified as a Class II medical device.
Frequently asked questions
What is the Anchored Beacon transponder used for?
The Anchored Beacon transponder is designed to be permanently implanted in the lung and serves as a fiducial marker for tracking and positioning during radiation therapy procedures. It helps clinicians precisely target radiation treatment areas.
How is the Anchored Beacon transponder supplied?
The Anchored Beacon transponder is supplied as part of the Beacon Care Package - Lung. It is intended for single-use only and should not be reused or resterilized for patient safety and regulatory compliance.
What is the regulatory status of the Anchored Beacon transponder?
The Anchored Beacon transponder has FDA 510(k) clearance with product code IYE and is classified as a Class II medical device. It received clearance on April 6, 2018, after being received by the FDA on February 27, 2017.
Is the Anchored Beacon transponder sterile?
The device is supplied as part of a care package and is intended for single-use. While sterility is implied for implantable medical devices, the specific sterilization method is not detailed in the provided information.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Anchored Beacon (R) transponder, Anchored transponder, Beacon Care ..., PDF K170570 S002 - Food and Drug Administration, Anchored Beacon(R) transponder, Anchored transponder, Beacon Care ..., PDF K170570 Anchored Beacon(R) transponder, Anchored transponder, Beacon ..., Anchored Beacon (R) transponder, Anchored transponder, Beacon Care ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K170570 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Varian Medical Systems, Inc.
Sources (1)
- FDA 510(k) K170570 24 fields · synced Oct 6, 2026