FDA Product Code
FDA Product Code JAQ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.5700
510(k) Clearances — 208 records · page 1 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262383 | LumenCare Azure | Nucletron B.V. | 2026-07-24 | Special | PDF ↗ |
| K252717 | MAASTRO Rectal Applicator Set | Varian Medical Systems | 2026-05-20 | Traditional | PDF ↗ |
| K251037 | Rectal Applicator | Nucletron B.V. | 2025-12-19 | Traditional | PDF ↗ |
| K252884 | Guided Aarhus Applicator Set | Varian Medical Systems | 2025-11-19 | Traditional | PDF ↗ |
| K250299 | CT/ MR Tandem and Ovoid Set | Varian Medical Systems, Inc. | 2025-05-09 | Traditional | PDF ↗ |
| K250289 | Intracavitary/Interstitial System | Varian Medical Systems | 2025-04-25 | Traditional | PDF ↗ |
| K243939 | Titanium Flexible Geometry FSD Applicator Set (GM11013400) | Varian Medical Systems, Inc. | 2025-03-03 | Traditional | PDF ↗ |
| K241764 | Mould Probe MR Safe | Varian Medical Systems, Inc. | 2025-01-10 | Traditional | PDF ↗ |
| K242961 | Intraluminal Applicator Set | Varian Medical Systems | 2024-11-26 | Traditional | PDF ↗ |
| K243045 | BRAXX Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002) | Braxx Biotech Co., Ltd. | 2024-11-19 | Special | PDF ↗ |
| K241853 | Titanium Fletcher-Style Applicator Set Defined Geometry; Smit Cervical Sleeve | Varian Medical Systems, Inc. | 2024-11-07 | Traditional | PDF ↗ |
| K241965 | Catheter Surface Flap Applicator Set (GM11011830) | Varian Medical Systems | 2024-10-29 | Traditional | PDF ↗ |
| K241386 | Heyman Packing Applicator Set (GM11004580) | Varian Medical Systems, Inc. | 2024-08-30 | Traditional | PDF ↗ |
| K233628 | AOS Interstitial Templates, Needles, and Accessories | Alpha-Omega Services, Inc. | 2024-07-10 | Traditional | PDF ↗ |
| K233626 | AOS Marker Seeds (SMG0242-025) | Alpha-Omega Services, Inc. | 2024-07-02 | Traditional | PDF ↗ |
| K240495 | Flexible Fixation Device for Gynecological Applicators (GM11001960) | Varian Medical Systems, Inc. | 2024-05-09 | Traditional | PDF ↗ |
| K232623 | Universal Endometrial Applicator Set (GM11009840) | Varian Medical Systems, Inc. | 2024-04-09 | Traditional | PDF ↗ |
| K232949 | Kelowna GYN and Crook Prostate Templates | Varian Medical Systems, Inc. | 2024-02-01 | Traditional | PDF ↗ |
| K230155 | Mick Valencia Applicator Set | Mick Radio-Nuclear Instruments, Inc. | 2023-08-30 | Traditional | PDF ↗ |
| K222775 | Aarhus Applicator Set | Varian Medical Systems, Inc. | 2023-03-13 | Traditional | PDF ↗ |
| K221797 | BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes and Length Assessment Device | Varian Medical Systems, Inc. | 2022-09-14 | Traditional | PDF ↗ |
| K193240 | Universal Cylinder Applicator Family | Varian Medical Systems, Inc. | 2020-08-17 | Traditional | PDF ↗ |
| K201272 | Geneva | Nucletron B.V. | 2020-07-16 | Traditional | PDF ↗ |
| K201279 | ASSISTO Universal Applicator Clamping Device | Geomed Medizin-Technik GmbH & Co. KG | 2020-07-10 | Traditional | PDF ↗ |
| 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 Applicator Sets, CT HDR Ring & Tandem Applicator with Rectal Retractor | Mick Radio-Nuclear Instruments, Inc. | 2020-02-28 | Special | PDF ↗ |
| K191580 | BRAVOS Afterloader System, Transfer Guide Tubes, Length Assessment Device | Varian Medical Systems, Inc. | 2019-07-08 | Special | PDF ↗ |
| K183332 | BRAXX Esophageal Brachytherapy Applicator | Braxx Biotech Co., Ltd. | 2019-04-16 | Traditional | PDF ↗ |
| K172533 | GM Implant Tubes, Length Cutting Gauge | Varian Medical Systems, Inc. | 2018-10-22 | Traditional | PDF ↗ |
| K181903 | BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes, and Length Assessment Device | Varian Medical Systems, Inc. | 2018-10-03 | Traditional | PDF ↗ |
| K172675 | Varian Cervical Sleeves | Varian Medical Systems, Inc. | 2018-05-16 | Traditional | PDF ↗ |
| K180069 | HDR MRI Lumen Marker | C4 Imaging, LLC | 2018-04-27 | Traditional | PDF ↗ |
| K162499 | Best Instruminal Applicator | Best Medical International, Inc. | 2018-04-13 | Traditional | PDF ↗ |
| K172611 | Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Universal Cervix Probe Sets, odd lengths and even lengths, Universal Titanium Cervix Probe Sets, odd lengths and even lengths | Varian Medical Systems, Inc. | 2018-03-21 | Special | PDF ↗ |
| K171631 | Standard Catheter Set | Varian Medical Systems, Inc. | 2018-02-09 | Traditional | PDF ↗ |
| K162533 | Kelowna GYN and Crook Prostate Templates | Varian Medical Systems, Inc. | 2017-08-31 | Traditional | PDF ↗ |
| K170203 | System, Applicator, Radionuclide, Remote Controlled | Kobold, LLC | 2017-06-01 | Traditional | PDF ↗ |
| K162615 | Mould Applicator Set | Varian Medical Systems, Inc. | 2017-03-24 | Traditional | PDF ↗ |
| K160815 | Interstitial Needles | Varian Medical Systems, Inc. | 2017-03-10 | Traditional | PDF ↗ |
| K162018 | Surface Applicator Set | Varian Medical Systems, Inc. | 2017-02-28 | Traditional | PDF ↗ |
| K160610 | Kobold Fletcher-model Tandem and Ovoid Applicator Set, Kobold Henschke-model Tandem and Ovoid Applicator Set, Kobold Vaginal Cylinder Applicator Set, Kobold Miami Cylinder Applicator Set | Kobold, LLC | 2017-02-13 | Traditional | PDF ↗ |
| K161688 | Advanced Gynecological Applicator | Nucletron B.V. | 2017-01-27 | Traditional | PDF ↗ |
| K160045 | Heyman Packing Applicator Set | Varian Medical Systems, Inc. | 2016-11-17 | Traditional | PDF ↗ |
| K161540 | Advanced Breast Template System | Varian Medical Systems, Inc. | 2016-10-20 | Traditional | PDF ↗ |
| K161576 | Esophagus Bougie Set | Varian Medical Systems, Inc. | 2016-10-02 | Traditional | PDF ↗ |
| K160516 | Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Universal Cervix Probe Set, odd lengths, Universal Cervix Probe Set, even lengths | Varian Medical Systems, Inc. | 2016-08-10 | Traditional | PDF ↗ |
| K150979 | CT/MR Compatible M.A.C. Interstitial GYN Template | Mick Radio-Nuclear Instruments, Inc. | 2016-05-31 | Traditional | PDF ↗ |
| K160021 | Varian Sterilization Boxes | Varian Medical Systems, Inc. | 2016-04-13 | Traditional | PDF ↗ |
| K151022 | Intraluminal Applicator Set | Varian Medical Systems, Inc. | 2015-12-17 | Traditional | PDF ↗ |
| K152018 | Varian Cleaning Caps, Varian Leak Stop Buttons, Varian Leak Stop Channel Marker Sets | Varian Medical Systems, Inc. | 2015-09-11 | Traditional | PDF ↗ |
| K151657 | Shielded Applicator Set, Cervical Stop | Varian Medical Systems, Inc. | 2015-08-07 | Traditional | PDF ↗ |
| K150839 | 3D Interstitial Ring Applicator Set 60, 3D Interstitial Ring Applicator Set 90, Ring Applicator Set 45, Ring Applicator Set 60, Ring Applicator Set 90 | Varian Medical Systems, Inc. | 2015-07-17 | Traditional | PDF ↗ |
| K151272 | Henschke Titanium Applicator Set | Nucletron B.V. | 2015-06-23 | Traditional | PDF ↗ |
| K142719 | E-App | Gc Medtech, LLC | 2015-05-20 | Traditional | PDF ↗ |
| K142986 | SagiNova | Eckert & Ziegler Bebig GmbH | 2015-04-17 | Traditional | PDF ↗ |
| K142330 | Kobold Ring and Tandem Applicator Set | Kobold, LLC | 2015-04-09 | Traditional | PDF ↗ |
| K141624 | PLASTIC NEEDLE WITH MANDRIN, 2.0 MM DIAMETER, LENGTH, BLUNT TIP,PLASTIC NEEDLE WITH MANDRIN, 2.0 MM DIAMETER, LENGTH 113 | Varian Medical Systems, Inc. | 2015-03-10 | Traditional | PDF ↗ |
| K142439 | Martinez Prostate Template Set | Nucletron B.V. | 2015-03-10 | Traditional | PDF ↗ |
| K142597 | Vienna System | Mick Radio-Nuclear Instruments, Inc. | 2015-02-19 | Traditional | PDF ↗ |
| K141490 | UNIVERSAL SEGMENTED CYLINDER APPLICATOR SET AND UNIVERSAL STUMP APPLICATOR SET | Varian Medical Systems, Inc. | 2014-09-26 | Traditional | PDF ↗ |
| K141336 | SOURCE GUIDE TUBE WITH LOCKING MECHANISM FOR 113 MM NEEDLES, GAMMAMEDPLUS | Varian Medical Systems, Inc. | 2014-08-06 | Traditional | PDF ↗ |
| K140803 | LUNERAY;CATHETER 6F 50CM, NEEDLE 37MM R30MM/47MM R45MM/57MM R60MM/67MM R75 MM | Nucletron B.V. | 2014-06-26 | Traditional | PDF ↗ |
| K133922 | GENTLECARE AR APPLICATOR | Gc Medtech, LLC | 2014-04-18 | Traditional | PDF ↗ |
| K130757 | KOBOLD SECURE LOCK TRANSFER GUIDE TUBE SET; KOBOLD LUER TRANSFER GUIDE TUBE SET | Spencer Fillmore | 2014-04-03 | Traditional | PDF ↗ |
| K132889 | FLETCHER CT/MR SHIELDED APPLICATOR SET (6 MM) FLETCHER CT/MR SHIELDED APPLICATOR SET (4 MM) | Nucletron B.V. | 2014-02-26 | Traditional | PDF ↗ |
| K132874 | LUMENCARE AZURE SET F6, 150CM, LUMECARE AZURE SET 5F, 150 CM, LUMENCARE AZURE SET 5F, 140 CM | Nucletron B.V. | 2014-02-21 | Special | PDF ↗ |
| K132097 | BEST MULTI-LUMEN BALLOON APPLICATOR FOR BRACHYTHERAPY | Best Medical International, Inc. | 2013-09-30 | Traditional | PDF ↗ |
| K123912 | KOBOLD FLETCHER TYPE APPLICATOR SET, KOBOLD HENSCHKE TYPE APPLICATOR SET | Spencer Fillmore | 2013-05-14 | Traditional | PDF ↗ |
| K123941 | KOBOLD SURE-GUIDE VAGINAL CYLINDER SET, STUMP VAGINAL CYLINDER SET, MIAMI CYLINDER SET | Spencer Fillmore | 2013-04-30 | Traditional | PDF ↗ |
| K130251 | ESOPHAGUS BOUGIE SET | Varian Medical Systems, Inc. | 2013-03-13 | Traditional | PDF ↗ |
| K123815 | SURFACE APPLICATOR SET WITH LEIPZIG-STYLE CONE | Varian Medical Systems, Inc. | 2013-03-11 | Traditional | PDF ↗ |
| K123442 | XOFT AXXENT CERVICAL APPLICATORS | Icad, Inc. | 2013-02-27 | Traditional | PDF ↗ |
| K122840 | CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR MODEL 0407 | Mick Radio-Nuclear Instruments, Inc. | 2012-12-14 | Traditional | PDF ↗ |
| K122236 | VARISOURSE IX BRAHYTHERAPY AFTERLOADER VARISOURCE IX (T) BRACHYTHERAPY AFTERLOADER | Varian Medical Systems, Inc. | 2012-11-16 | Traditional | PDF ↗ |
| K120993 | GAMMAMEDPLUS IX BRACHYTHERAPY AFTERLOADER, GAMMAMEDPLUS 3/24 IX BRACHYTHERAPY AFTERLOADER | Varian Medical Systems, Inc. | 2012-07-26 | Traditional | PDF ↗ |
| K120731 | TITANIUM FLETCHER-STYLE APPLICATOR SET-DEFINED GEOMETRY | Varian Medical Systems, Inc. | 2012-06-06 | Traditional | PDF ↗ |
| K120344 | RADIAPAK BRACHYTHERAPY APPLICATOR BALLOON DEVICE | Radiadyne, LLC (Specification Developer) | 2012-05-03 | Traditional | PDF ↗ |
| K120341 | PLASTIC NEEDLE WITH MANDRIN 2.0 DIAMETER LENGTH 113MM | Varian Medical Systems, Inc. | 2012-04-27 | Traditional | PDF ↗ |
| K113766 | CLICKFIT TRANSFER GUIDE TUBES NEEDLE CLICKFIT TRANSFER GUIDE TUBES CATHETER TRANSFER GUIDE TUBE SET VARISOURCE LUER TRAN | Varian Medical Systems, Inc. | 2012-03-16 | Traditional | PDF ↗ |
| K112420 | ONCENTRA PROSTATE 4.0 | Nucletron | 2011-11-18 | Traditional | PDF ↗ |
| K111973 | VAGINAL CT / MR MULTI CHANNEL APPLICATOR SET | Nucletron | 2011-09-21 | Special | PDF ↗ |
| K103215 | CIANNA S1, SINGLE LUMEN BALLOON APPLICATOR KIT | Cianna Medical | 2010-11-15 | Traditional | PDF ↗ |
| K101411 | SAVI PREPARATION DEVICE | Cianna Medical, Inc. | 2010-07-12 | Traditional | PDF ↗ |
| K092534 | ALATUS VAGINAL BALLOON PACKING SYSTEM | Radiadyne | 2009-12-07 | Traditional | PDF ↗ |
| K093291 | VARIAN INTERSTITIAL TITANIUM NEEDLES | Varian Medical Systems, Inc. | 2009-11-17 | Special | PDF ↗ |
| K092822 | CAPRI APPLICATOR | Vivaray, Inc. | 2009-11-03 | Traditional | PDF ↗ |
| K092804 | MICROSELECTRON HDR V2, MODEL 105.999 | Nucletron Corp. | 2009-10-08 | Special | PDF ↗ |
| K092405 | MAMMOSITE MULTI LUMEN | Hologic, Inc. | 2009-08-27 | Special | PDF ↗ |
| K092323 | CONTURA CAVITY MAINTENANCE CATHETER | Senorx, Inc. | 2009-08-19 | Traditional | PDF ↗ |
| K091230 | HDR PROSTATE TEMPLATE AND ACCESSORIES | Photon Technologies Corporation | 2009-08-12 | Traditional | PDF ↗ |
| K091378 | MAMMOSITE II RADIATION THERAPY SYSTEM | Hologic, Inc. | 2009-07-02 | Special | PDF ↗ |
| K091598 | LUMENCATH APPLICATOR SET, MODELS 189. 795, 189.796, 189.797, 189.798, LUMENCATH CATHETERS | Nucletron Corp. | 2009-06-29 | Special | PDF ↗ |
| K091154 | UTRECHT INTERSTITIAL FLETCHER CT/MR APPLICATOR SET, MODEL 110.270, INTERSTITIAL RING CT/MR APPLICATOR SET,MODEL 110.330, | Nucletron Corporation | 2009-05-18 | Special | PDF ↗ |
| K082530 | APPLICATORS FOR AFTERLOADING BRACHYTHERAPY | Isodose Control B.V. | 2008-10-30 | Abbreviated | PDF ↗ |
| K082653 | CENTERING INTRALUMINAL APPLICATOR | Varian Medical Systems, Inc. | 2008-10-10 | Special | PDF ↗ |
| K082264 | CONTURA LUMEN MARKER | Senorx, Inc. | 2008-09-12 | Traditional | PDF ↗ |
| K081677 | SAVI APPLICATOR KIT | Cianna Medical, Inc. | 2008-07-22 | Special | PDF ↗ |
| K080934 | VIENNA RING CT/MR APPLICATOR SET, ROUND POINT TITANIUM NEEDLE SET, TROCAR POINT TITANIUM NEEDLE SET | Nucletron Corporation | 2008-05-28 | Traditional | PDF ↗ |
| K081179 | MAMMOSITE CAVITY EVALUATION DEVICE | Hologic, Inc. | 2008-05-09 | Traditional | PDF ↗ |
| K081079 | CONTURA MLB SOURCE APPLICATOR FOR BRACHYTHERAPY | Senorx, Inc. | 2008-05-02 | Traditional | PDF ↗ |
| K080791 | CONTURA MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRACHYTHERAPY, MODELS B001-45 AND B011-45 | Senorx, Inc. | 2008-04-30 | Traditional | PDF ↗ |
Product code JAQ · Class II · Radiology. Data: openFDA.