System, Applicator, Radionuclide, Remote-Controlled
Regulation 892.5700
4510(k)s in 12 months (208 all time)
3recalls in 12 months (52 all time)
40recalls that name a 510(k)
Top companies in JAQ
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 24, 2026 | K262383 | LumenCare Azure Nucletron B.V., NL | JAQ |
| May 20, 2026 | K252717 | MAASTRO Rectal Applicator Set Varian Medical Systems | JAQ |
| Dec 19, 2025 | K251037 | Rectal Applicator Nucletron B.V., NL | JAQ |
| Nov 19, 2025 | K252884 | Guided Aarhus Applicator Set Varian Medical Systems | JAQ |
| May 9, 2025 | K250299 | CT/ MR Tandem and Ovoid Set Varian Medical Systems, Inc. | JAQ |
| Apr 25, 2025 | K250289 | Intracavitary/Interstitial System Varian Medical Systems | JAQ |
| Mar 3, 2025 | K243939 | Titanium Flexible Geometry FSD Applicator Set (GM11013400) Varian Medical Systems, Inc. | JAQ |
| Jan 10, 2025 | K241764 | Mould Probe MR Safe Varian Medical Systems, Inc. | JAQ |
| Nov 26, 2024 | K242961 | Intraluminal Applicator Set Varian Medical Systems | JAQ |
| Nov 19, 2024 | K243045 | BRAXX Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002) Braxx Biotech Co., Ltd., TW | JAQ |
| Nov 7, 2024 | K241853 | Titanium Fletcher-Style Applicator Set Defined Geometry; Smit Cervical Sleeve Varian Medical Systems, Inc. | JAQ |
| Oct 29, 2024 | K241965 | Catheter Surface Flap Applicator Set (GM11011830) Varian Medical Systems | JAQ |
| Aug 30, 2024 | K241386 | Heyman Packing Applicator Set (GM11004580) Varian Medical Systems, Inc. | JAQ |
| Jul 10, 2024 | K233628 | AOS Interstitial Templates, Needles, and Accessories Alpha-Omega Services, Inc. | JAQ |
| Jul 2, 2024 | K233626 | AOS Marker Seeds (SMG0242-025) Alpha-Omega Services, Inc. | JAQ |
| May 9, 2024 | K240495 | Flexible Fixation Device for Gynecological Applicators (GM11001960) Varian Medical Systems, Inc. | JAQ |
| Apr 9, 2024 | K232623 | Universal Endometrial Applicator Set (GM11009840) Varian Medical Systems, Inc. | JAQ |
| Feb 1, 2024 | K232949 | Kelowna GYN and Crook Prostate Templates Varian Medical Systems, Inc. | JAQ |
| Aug 30, 2023 | K230155 | Mick Valencia Applicator Set Mick Radio-Nuclear Instruments, Inc. | JAQ |
| Mar 13, 2023 | K222775 | Aarhus Applicator Set Varian Medical Systems, Inc. | JAQ |
| Sep 14, 2022 | K221797 | BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes and Length Assessment Device Varian Medical Systems, Inc. | JAQ |
| Aug 17, 2020 | K193240 | Universal Cylinder Applicator Family Varian Medical Systems, Inc. | JAQ |
| Jul 16, 2020 | K201272 | Geneva Nucletron B.V., NL | JAQ |
| Jul 10, 2020 | K201279 | ASSISTO Universal Applicator Clamping Device Geomed Medizin-Technik GmbH & Co. KG, DE | JAQ |
| Feb 28, 2020 | K200221 | CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid Applicators (Henschke), HDR CT Compatible Sp Mick Radio-Nuclear Instruments, Inc. | JAQ |
| Jul 8, 2019 | K191580 | BRAVOS Afterloader System, Transfer Guide Tubes, Length Assessment Device Varian Medical Systems, Inc. | JAQ |
| Apr 16, 2019 | K183332 | BRAXX Esophageal Brachytherapy Applicator Braxx Biotech Co., Ltd., TW | JAQ |
| Oct 22, 2018 | K172533 | GM Implant Tubes, Length Cutting Gauge Varian Medical Systems, Inc. | JAQ |
| Oct 3, 2018 | K181903 | BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes, and Length Assessment Device Varian Medical Systems, Inc. | JAQ |
| May 16, 2018 | K172675 | Varian Cervical Sleeves Varian Medical Systems, Inc. | JAQ |
| Apr 27, 2018 | K180069 | HDR MRI Lumen Marker C4 Imaging, LLC | JAQ |
| Apr 13, 2018 | K162499 | Best Instruminal Applicator Best Medical International, Inc. | JAQ |
| Mar 21, 2018 | K172611 | Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Unive Varian Medical Systems, Inc. | JAQ |
| Feb 9, 2018 | K171631 | Standard Catheter Set Varian Medical Systems, Inc. | JAQ |
| Aug 31, 2017 | K162533 | Kelowna GYN and Crook Prostate Templates Varian Medical Systems, Inc. | JAQ |
| Jun 1, 2017 | K170203 | System, Applicator, Radionuclide, Remote Controlled Kobold, LLC | JAQ |
| Mar 24, 2017 | K162615 | Mould Applicator Set Varian Medical Systems, Inc. | JAQ |
| Mar 10, 2017 | K160815 | Interstitial Needles Varian Medical Systems, Inc. | JAQ |
| Feb 28, 2017 | K162018 | Surface Applicator Set Varian Medical Systems, Inc. | JAQ |
| Feb 13, 2017 | K160610 | Kobold Fletcher-model Tandem and Ovoid Applicator Set, Kobold Henschke-model Tandem and Ovoid Applicator Set, Kobold Vag Kobold, LLC | JAQ |
| Jan 27, 2017 | K161688 | Advanced Gynecological Applicator Nucletron B.V., NL | JAQ |
| Nov 17, 2016 | K160045 | Heyman Packing Applicator Set Varian Medical Systems, Inc. | JAQ |
| Oct 20, 2016 | K161540 | Advanced Breast Template System Varian Medical Systems, Inc. | JAQ |
| Oct 2, 2016 | K161576 | Esophagus Bougie Set Varian Medical Systems, Inc. | JAQ |
| Aug 10, 2016 | K160516 | Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Unive Varian Medical Systems, Inc. | JAQ |
| May 31, 2016 | K150979 | CT/MR Compatible M.A.C. Interstitial GYN Template Mick Radio-Nuclear Instruments, Inc. | JAQ |
| Apr 13, 2016 | K160021 | Varian Sterilization Boxes Varian Medical Systems, Inc. | JAQ |
| Dec 17, 2015 | K151022 | Intraluminal Applicator Set Varian Medical Systems, Inc. | JAQ |
| Sep 11, 2015 | K152018 | Varian Cleaning Caps, Varian Leak Stop Buttons, Varian Leak Stop Channel Marker Sets Varian Medical Systems, Inc. | JAQ |
| Aug 7, 2015 | K151657 | Shielded Applicator Set, Cervical Stop Varian Medical Systems, Inc. | JAQ |
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