Product code JAQ
- Device name
- System, Applicator, Radionuclide, Remote-Controlled
- Medical specialty
- Radiology
- Device class
- 2
- Regulation number
- 892.5700
- Review panel
- RA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262383 | LumenCare Azure | Nucletron B.V. | 2026-07-24 |
| K252717 | MAASTRO Rectal Applicator Set | Varian Medical Systems | 2026-05-20 |
| K251037 | Rectal Applicator | Nucletron B.V. | 2025-12-19 |
| K252884 | Guided Aarhus Applicator Set | Varian Medical Systems | 2025-11-19 |
| K250299 | CT/ MR Tandem and Ovoid Set | Varian Medical Systems, Inc. | 2025-05-09 |
| K250289 | Intracavitary/Interstitial System | Varian Medical Systems | 2025-04-25 |
| K243939 | Titanium Flexible Geometry FSD Applicator Set (GM11013400) | Varian Medical Systems, Inc. | 2025-03-03 |
| K241764 | Mould Probe MR Safe | Varian Medical Systems, Inc. | 2025-01-10 |
| K242961 | Intraluminal Applicator Set | Varian Medical Systems | 2024-11-26 |
| K243045 | “BRAXX” Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002) | Braxx Biotech Co., Ltd. | 2024-11-19 |
| K241853 | Titanium Fletcher-Style Applicator Set Defined Geometry; Smit Cervical Sleeve | Varian Medical Systems, Inc. | 2024-11-07 |
| K241965 | Catheter Surface Flap Applicator Set (GM11011830) | Varian Medical Systems | 2024-10-29 |
| K241386 | Heyman Packing Applicator Set (GM11004580) | Varian Medical Systems, Inc. | 2024-08-30 |
| K233628 | AOS Interstitial Templates, Needles, and Accessories | Alpha-Omega Services, Inc. | 2024-07-10 |
| K233626 | AOS Marker Seeds (SMG0242-025) | Alpha-Omega Services, Inc. | 2024-07-02 |
| K240495 | Flexible Fixation Device for Gynecological Applicators (GM11001960) | Varian Medical Systems, Inc. | 2024-05-09 |
| K232623 | Universal Endometrial Applicator Set (GM11009840) | Varian Medical Systems, Inc. | 2024-04-09 |
| K232949 | Kelowna GYN and Crook Prostate Templates | Varian Medical Systems, Inc. | 2024-02-01 |
| K230155 | Mick Valencia Applicator Set | Mick Radio-Nuclear Instruments, Inc. | 2023-08-30 |
| K222775 | Aarhus Applicator Set | Varian Medical Systems, Inc. | 2023-03-13 |
| K221797 | BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes and Length Assessment Device | Varian Medical Systems, Inc. | 2022-09-14 |
| K193240 | Universal Cylinder Applicator Family | Varian Medical Systems, Inc. | 2020-08-17 |
| K201272 | Geneva | Nucletron B.V. | 2020-07-16 |
| K201279 | ASSISTO Universal Applicator Clamping Device | Geomed Medizin-Technik GmbH & Co. KG | 2020-07-10 |
| K200221 | CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid Applicators (Henschke), HDR CT Compatible Split Ring Applicator, Segmented Vaginal Applicator, HDR Miami Applicator HDR Brachytherapy Applicator, 2/3 Endometrial... | Mick Radio-Nuclear Instruments, Inc. | 2020-02-28 |
| K191580 | BRAVOS Afterloader System, Transfer Guide Tubes, Length Assessment Device | Varian Medical Systems, Inc. | 2019-07-08 |
| K183332 | “BRAXX” Esophageal Brachytherapy Applicator | Braxx Biotech Co., Ltd. | 2019-04-16 |
| K172533 | GM Implant Tubes, Length Cutting Gauge | Varian Medical Systems, Inc. | 2018-10-22 |
| K181903 | BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes, and Length Assessment Device | Varian Medical Systems, Inc. | 2018-10-03 |
| K172675 | Varian Cervical Sleeves | Varian Medical Systems, Inc. | 2018-05-16 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00841436125451 | Classic Stepper | CIVCO MEDICAL INSTRUMENTS CO., INC. | 2026-07-23 |
| 00810563022551 | Needle collector pair for Titanium Fletcher-style applicator | VARIAN MEDICAL SYSTEMS, INC. | 2024-11-19 |
| 00816389020245 | Crook Prostate Template for 2.0 mm needles | VARIAN MEDICAL SYSTEMS, INC. | 2024-02-19 |
| 00810563021974 | Plastic needle MR safe, 2.0 mm diameter x 320 mm length, with mandrin | VARIAN MEDICAL SYSTEMS, INC. | 2024-02-16 |
| 00810563021981 | Plastic needle MR safe, 2.0 mm diameter x 320 mm length, blunt tip, with mandrin | VARIAN MEDICAL SYSTEMS, INC. | 2024-02-16 |
| 00810563021998 | Mandrin for 113 mm length | VARIAN MEDICAL SYSTEMS, INC. | 2024-02-16 |
| 00810563022001 | Mandrin for 200 mm length | VARIAN MEDICAL SYSTEMS, INC. | 2024-02-16 |
| 00810563022018 | Mandrin for 320 mm length | VARIAN MEDICAL SYSTEMS, INC. | 2024-02-16 |
| 00810563022025 | Plastic needle MR safe, 2.0 mm diameter x 113 mm length, with mandrin | VARIAN MEDICAL SYSTEMS, INC. | 2024-02-16 |
| 00810563021967 | Plastic needle MR safe, 2.0 mm diameter x 200 mm length, with mandrin | VARIAN MEDICAL SYSTEMS, INC. | 2024-02-16 |
| 00816389022522 | Mandrin for 200mm length Needle for Plastic Interstitial Needle | VARIAN MEDICAL SYSTEMS, INC. | 2021-02-02 |
| 10816389027296 | Universal fixation button, radiopaque, pack of 100, non-sterile | VARIAN MEDICAL SYSTEMS, INC. | 2016-09-23 |
| 00816389022935 | Catheter flap 200 mm x 290 mm x 10 mm, 40 channels | VARIAN MEDICAL SYSTEMS, INC. | 2016-09-23 |
| 00816389021747 | Central clamping mechanism | VARIAN MEDICAL SYSTEMS, INC. | 2016-09-23 |
| 00816389022478 | Mandrin for 320mm length | VARIAN MEDICAL SYSTEMS, INC. | 2016-09-23 |
| 00816389021778 | Intrauterine probe with stop, 30 degrees angle, length 80mm | VARIAN MEDICAL SYSTEMS, INC. | 2016-09-23 |
| 10816389027234 | Cleaning Cap, dark blue (pack of 25) | VARIAN MEDICAL SYSTEMS, INC. | 2016-09-22 |
| 00816389021938 | Cervical sleeve 50 mm, with clamp for guide tube | VARIAN MEDICAL SYSTEMS, INC. | 2016-09-22 |
| 00816389025615 | Plastic needle 2.0 mm diameter, 320 mm length, blunt tip w/ mandrin | VARIAN MEDICAL SYSTEMS, INC. | 2016-09-22 |
| 00816389024243 | Plastic needle, 2.0 mm diameter, 113 mm length with mandrin for 113 mm needles | VARIAN MEDICAL SYSTEMS, INC. | 2016-09-22 |
| 00816389022553 | Mandrin for 113mm length Needle | VARIAN MEDICAL SYSTEMS, INC. | 2016-09-22 |
| 00816389022188 | Flexible probe, 2.8 mm diameter x 320 mm | VARIAN MEDICAL SYSTEMS, INC. | 2016-09-22 |
| 00816389024267 | Plastic needle ø 2.0 mm diameter, 320 mm length with mandrin for 320 mm needles | VARIAN MEDICAL SYSTEMS, INC. | 2016-09-19 |
| 00816389021242 | Titanium-Fletcher-Suit-Delclos-style Applicator Set (Flexible Geometry) | VARIAN MEDICAL SYSTEMS, INC. | 2016-09-19 |
| 00816389021297 | X-ray marker wire, 160 cm x 0.6, channel 1 | VARIAN MEDICAL SYSTEMS, INC. | 2016-09-19 |
| 00816389021310 | X-ray marker wire, 160 cm x 0.6, channel 3 | VARIAN MEDICAL SYSTEMS, INC. | 2016-09-19 |
| 00816389022195 | Mould probe, ø 1.8 diameter x 320 mm, with mandrin | VARIAN MEDICAL SYSTEMS, INC. | 2016-09-19 |
| 00816389021792 | Colpostats for 20mm spread, pair | VARIAN MEDICAL SYSTEMS, INC. | 2016-09-19 |
| 00816389021808 | Colpostats for 25mm spread, pair | VARIAN MEDICAL SYSTEMS, INC. | 2016-09-19 |
| 00816389024250 | Plastic needle 2.0 mm diameter, 200 mm length with mandrin for 200 mm needles | VARIAN MEDICAL SYSTEMS, INC. | 2016-09-18 |