Cleared Traditional

Anchored Beacon(R) transponder, Anchored transponder, Beacon Care Package - Lung (K170570) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence.

K170570 · Varian Medical Systems, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2018
Decision
403d
Days
Class 2
Risk

K170570 is an FDA 510(k) clearance for the Anchored Beacon(R) transponder, Anchored transponder, Beacon Care Package - Lung. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Varian Medical Systems, Inc. (Palo Alto, US). The FDA issued a Cleared decision on April 6, 2018 after a review of 403 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Radiology submissions.

View all Varian Medical Systems, Inc. devices

Submission Details

510(k) Number K170570 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2017
Decision Date April 06, 2018
Days to Decision 403 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
296d slower than avg
Panel avg: 107d · This submission: 403d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IYE Accelerator, Linear, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Radiology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01396551 Completed Interventional Industry-sponsored

Evaluating an Anchored Transponder in Lung Cancer Patients Receiving Radiation Therapy

69
Patients (actual)
10
Sites
Other
Purpose
Open label
Masking
Condition studied Lung Cancer
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Lisa Levine, PhD
Sponsor Varian, a Siemens Healthineers Company (industry)
Started 2010-10-01 → Primary completion 2016-12-01 → Completed 2017-01-01
Primary outcome
To Determine the Proportion of Patients Who Can be Localized by the Calypso System Using the Anchored Transponders.
Secondary outcome
To Assess the Implantation Procedure of the Anchored Transponder in the Lung
View full study on ClinicalTrials.gov

Regulatory Peers - IYE Accelerator, Linear, Medical

All 732
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K170570.
LUNA 3D
K253004 · Lap GmbH Laser Applikationen · Jun 2026
AerFrame Patient Immobilization System (AFPIS)
K260792 · Stabilix, LLC · May 2026
VERIQA RT EPID 3D
K252258 · Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla · Apr 2026
ClearCheck (RADCC V2.7)
K253962 · Radformation, Inc. · Apr 2026
AlignRT Plus (8.0)
K253012 · Vision Rt, Ltd. · Mar 2026
Halcyon, Ethos Radiotherapy System (5.0)
K252977 · Varian Medical Systems, Inc. · Jan 2026