Cleared Traditional

K252884 - Guided Aarhus Applicator Set
(FDA 510(k) Clearance)

K252884 · Varian Medical Systems · Radiology

Nov 2025

Decision

70d

Days

Class 2

Risk

K252884 is an FDA 510(k) clearance for the Guided Aarhus Applicator Set. This device is classified as a System, Applicator, Radionuclide, Remote-controlled (Class II — Special Controls, product code JAQ).

Submitted by Varian Medical Systems (Palo Alto, US). The FDA issued a Cleared decision on November 19, 2025, 70 days after receiving the submission on September 10, 2025.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5700.

Submission Details

510(k) Number	K252884 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 10, 2025
Decision Date	November 19, 2025
Days to Decision	70 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF