Cleared Traditional

CT/ MR Tandem and Ovoid Set

K250299 · Varian Medical Systems, Inc. · Radiology
May 2025
Decision
98d
Days
Class 2
Risk

About This 510(k) Submission

K250299 is an FDA 510(k) clearance for the CT/ MR Tandem and Ovoid Set, a System, Applicator, Radionuclide, Remote-controlled (Class II — Special Controls, product code JAQ), submitted by Varian Medical Systems, Inc. (Palo Alto, US). The FDA issued a Cleared decision on May 9, 2025, 98 days after receiving the submission on January 31, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5700.

Submission Details

510(k) Number K250299 FDA.gov
FDA Decision Cleared SESE
Date Received January 31, 2025
Decision Date May 09, 2025
Days to Decision 98 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code JAQ — System, Applicator, Radionuclide, Remote-controlled
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.5700

Similar Devices — JAQ System, Applicator, Radionuclide, Remote-controlled

All 205
Rectal Applicator
K251037 · Nucletron B.V. · Dec 2025
Guided Aarhus Applicator Set
K252884 · Varian Medical Systems · Nov 2025
Intracavitary/Interstitial System
K250289 · Varian Medical Systems · Apr 2025
Titanium Flexible Geometry FSD Applicator Set (GM11013400)
K243939 · Varian Medical Systems, Inc. · Mar 2025
Mould Probe MR Safe
K241764 · Varian Medical Systems, Inc. · Jan 2025
Intraluminal Applicator Set
K242961 · Varian Medical Systems · Nov 2024