JAQ
- Product code
- JAQ
- Device name
- System, Applicator, Radionuclide, Remote-Controlled
- Device class
- Class 2
- 21 CFR
- 21 CFR 892.5700
- Medical specialty
- Radiology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 208
510(k) clearances, last 3 years (18)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K262383 | 2026-07-24 | Nucletron B.V. | LumenCare Azure | |
| K252717 | 2026-05-20 | Varian Medical Systems | MAASTRO Rectal Applicator Set | FDA |
| K251037 | 2025-12-19 | Nucletron B.V. | Rectal Applicator | |
| K252884 | 2025-11-19 | Varian Medical Systems | Guided Aarhus Applicator Set | |
| K250299 | 2025-05-09 | Varian Medical Systems, Inc. | CT/ MR Tandem and Ovoid Set | |
| K250289 | 2025-04-25 | Varian Medical Systems | Intracavitary/Interstitial System | FDA |
| K243939 | 2025-03-03 | Varian Medical Systems, Inc. | Titanium Flexible Geometry FSD Applicator Set (GM110 | |
| K241764 | 2025-01-10 | Varian Medical Systems, Inc. | Mould Probe MR Safe | FDA |
| K242961 | 2024-11-26 | Varian Medical Systems | Intraluminal Applicator Set | |
| K243045 | 2024-11-19 | Braxx Biotech Co., Ltd. | BRAXX Esophageal Brachytherapy Applicator (Model: | |
| K241853 | 2024-11-07 | Varian Medical Systems, Inc. | Titanium Fletcher-Style Applicator Set Defined Geome | |
| K241965 | 2024-10-29 | Varian Medical Systems | Catheter Surface Flap Applicator Set (GM11011830) | |
| K241386 | 2024-08-30 | Varian Medical Systems, Inc. | Heyman Packing Applicator Set (GM11004580) | |
| K233628 | 2024-07-10 | Alpha-Omega Services, Inc. | AOS Interstitial Templates, Needles, and Accessories | |
| K233626 | 2024-07-02 | Alpha-Omega Services, Inc. | AOS Marker Seeds (SMG0242-025) | |
| K240495 | 2024-05-09 | Varian Medical Systems, Inc. | Flexible Fixation Device for Gynecological Applicato | |
| K232623 | 2024-04-09 | Varian Medical Systems, Inc. | Universal Endometrial Applicator Set (GM11009840) | |
| K232949 | 2024-02-01 | Varian Medical Systems, Inc. | Kelowna GYN and Crook Prostate Templates |
Official FDA classification page: JAQ
Classification and pathway per current FDA publications. Data from openFDA (CC0).