JAQ · System, Applicator, Radionuclide, Remote-Controlled
Radiology · 21 CFR 892.5700 · Class 2
Overview
| Product Code | JAQ |
|---|---|
| Device Name | System, Applicator, Radionuclide, Remote-Controlled |
| Regulation | 21 CFR 892.5700 |
| Device Class | Class 2 |
| Review Panel | Radiology |
Identification
A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 206)
Showing 20 most recent of 206 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251037 | Rectal Applicator | Nucletron B.V. | Dec 19, 2025 | SESE |
| K252884 | Guided Aarhus Applicator Set | Varian Medical Systems | Nov 19, 2025 | SESE |
| K250299 | CT/ MR Tandem and Ovoid Set | Varian Medical Systems, Inc. | May 9, 2025 | SESE |
| K250289 | Intracavitary/Interstitial System | Varian Medical Systems | Apr 25, 2025 | SESE |
| K243939 | Titanium Flexible Geometry FSD Applicator Set (GM11013400) | Varian Medical Systems, Inc. | Mar 3, 2025 | SESE |
| K241764 | Mould Probe MR Safe | Varian Medical Systems, Inc. | Jan 10, 2025 | SESE |
| K242961 | Intraluminal Applicator Set | Varian Medical Systems | Nov 26, 2024 | SESE |
| K243045 | BRAXX Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002) | Braxx Biotech Co., Ltd. | Nov 19, 2024 | SESE |
| K241853 | Titanium Fletcher-Style Applicator Set Defined Geometry; Smit Cervical Sleeve | Varian Medical Systems, Inc. | Nov 7, 2024 | SESE |
| K241965 | Catheter Surface Flap Applicator Set (GM11011830) | Varian Medical Systems | Oct 29, 2024 | SESE |
| K241386 | Heyman Packing Applicator Set (GM11004580) | Varian Medical Systems, Inc. | Aug 30, 2024 | SESE |
| K233628 | AOS Interstitial Templates, Needles, and Accessories | Alpha-Omega Services, Inc. | Jul 10, 2024 | SESE |
| K233626 | AOS Marker Seeds (SMG0242-025) | Alpha-Omega Services, Inc. | Jul 2, 2024 | SESE |
| K240495 | Flexible Fixation Device for Gynecological Applicators (GM11001960) | Varian Medical Systems, Inc. | May 9, 2024 | SESE |
| K232623 | Universal Endometrial Applicator Set (GM11009840) | Varian Medical Systems, Inc. | Apr 9, 2024 | SESE |
| K232949 | Kelowna GYN and Crook Prostate Templates | Varian Medical Systems, Inc. | Feb 1, 2024 | SESE |
| K230155 | Mick Valencia Applicator Set | Mick Radio-Nuclear Instruments, Inc. | Aug 30, 2023 | SESE |
| K222775 | Aarhus Applicator Set | Varian Medical Systems, Inc. | Mar 13, 2023 | SESE |
| K221797 | BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes and Length Assessment Device | Varian Medical Systems, Inc. | Sep 14, 2022 | SESE |
| K193240 | Universal Cylinder Applicator Family | Varian Medical Systems, Inc. | Aug 17, 2020 | SESE |
Top Applicants
- Varian Medical Systems, Inc. — 50 clearances
- Mick Radio-Nuclear Instruments, Inc. — 22 clearances
- Nucletron Corp. — 14 clearances
- Nucletron Corporation — 10 clearances
- Nucletron B.V. — 8 clearances
