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 17, 2015 | K150839 | 3D Interstitial Ring Applicator Set 60, 3D Interstitial Ring Applicator Set 90, Ring Applicator Set 45, Ring Applicator Varian Medical Systems, Inc. | JAQ |
| Jun 23, 2015 | K151272 | Henschke Titanium Applicator Set Nucletron B.V., NL | JAQ |
| May 20, 2015 | K142719 | E-App Gc Medtech, LLC | JAQ |
| Apr 17, 2015 | K142986 | SagiNova Eckert & Ziegler Bebig GmbH, DE | JAQ |
| Apr 9, 2015 | K142330 | Kobold Ring and Tandem Applicator Set Kobold, LLC | JAQ |
| Mar 10, 2015 | K142439 | Martinez Prostate Template Set Nucletron B.V., NL | JAQ |
| Mar 10, 2015 | 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. | JAQ |
| Feb 19, 2015 | K142597 | Vienna System Mick Radio-Nuclear Instruments, Inc. | JAQ |
| Sep 26, 2014 | K141490 | UNIVERSAL SEGMENTED CYLINDER APPLICATOR SET AND UNIVERSAL STUMP APPLICATOR SET Varian Medical Systems, Inc. | JAQ |
| Aug 6, 2014 | K141336 | SOURCE GUIDE TUBE WITH LOCKING MECHANISM FOR 113 MM NEEDLES, GAMMAMEDPLUS Varian Medical Systems, Inc. | JAQ |
| Jun 26, 2014 | K140803 | LUNERAY;CATHETER 6F 50CM, NEEDLE 37MM R30MM/47MM R45MM/57MM R60MM/67MM R75 MM Nucletron B.V., NL | JAQ |
| Apr 18, 2014 | K133922 | GENTLECARE AR APPLICATOR Gc Medtech, LLC | JAQ |
| Apr 3, 2014 | K130757 | KOBOLD SECURE LOCK TRANSFER GUIDE TUBE SET; KOBOLD LUER TRANSFER GUIDE TUBE SET Spencer Fillmore | JAQ |
| Feb 26, 2014 | K132889 | FLETCHER CT/MR SHIELDED APPLICATOR SET (6 MM) FLETCHER CT/MR SHIELDED APPLICATOR SET (4 MM) Nucletron B.V., NL | JAQ |
| Feb 21, 2014 | K132874 | LUMENCARE AZURE SET F6, 150CM, LUMECARE AZURE SET 5F, 150 CM, LUMENCARE AZURE SET 5F, 140 CM Nucletron B.V., NL | JAQ |
| Sep 30, 2013 | K132097 | BEST MULTI-LUMEN BALLOON APPLICATOR FOR BRACHYTHERAPY Best Medical International, Inc. | JAQ |
| May 14, 2013 | K123912 | KOBOLD FLETCHER TYPE APPLICATOR SET, KOBOLD HENSCHKE TYPE APPLICATOR SET Spencer Fillmore | JAQ |
| Apr 30, 2013 | K123941 | KOBOLD SURE-GUIDE VAGINAL CYLINDER SET, STUMP VAGINAL CYLINDER SET, MIAMI CYLINDER SET Spencer Fillmore | JAQ |
| Mar 13, 2013 | K130251 | ESOPHAGUS BOUGIE SET Varian Medical Systems, Inc. | JAQ |
| Mar 11, 2013 | K123815 | SURFACE APPLICATOR SET WITH LEIPZIG-STYLE CONE Varian Medical Systems, Inc. | JAQ |
| Feb 27, 2013 | K123442 | XOFT AXXENT CERVICAL APPLICATORS Icad, Inc. | JAQ |
| Dec 14, 2012 | K122840 | CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR MODEL 0407 Mick Radio-Nuclear Instruments, Inc. | JAQ |
| Nov 16, 2012 | K122236 | VARISOURSE IX BRAHYTHERAPY AFTERLOADER VARISOURCE IX (T) BRACHYTHERAPY AFTERLOADER Varian Medical Systems, Inc. | JAQ |
| Jul 26, 2012 | K120993 | GAMMAMEDPLUS IX BRACHYTHERAPY AFTERLOADER, GAMMAMEDPLUS 3/24 IX BRACHYTHERAPY AFTERLOADER Varian Medical Systems, Inc. | JAQ |
| Jun 6, 2012 | K120731 | TITANIUM FLETCHER-STYLE APPLICATOR SET-DEFINED GEOMETRY Varian Medical Systems, Inc. | JAQ |
| May 3, 2012 | K120344 | RADIAPAK BRACHYTHERAPY APPLICATOR BALLOON DEVICE Radiadyne, LLC (Specification Developer) | JAQ |
| Apr 27, 2012 | K120341 | PLASTIC NEEDLE WITH MANDRIN 2.0 DIAMETER LENGTH 113MM Varian Medical Systems, Inc. | JAQ |
| Mar 16, 2012 | K113766 | CLICKFIT TRANSFER GUIDE TUBES NEEDLE CLICKFIT TRANSFER GUIDE TUBES CATHETER TRANSFER GUIDE TUBE SET VARISOURCE LUER TRAN Varian Medical Systems, Inc. | JAQ |
| Nov 18, 2011 | K112420 | ONCENTRA PROSTATE 4.0 Nucletron | JAQ |
| Sep 21, 2011 | K111973 | VAGINAL CT / MR MULTI CHANNEL APPLICATOR SET Nucletron | JAQ |
| Nov 15, 2010 | K103215 | CIANNA S1, SINGLE LUMEN BALLOON APPLICATOR KIT Cianna Medical | JAQ |
| Jul 12, 2010 | K101411 | SAVI PREPARATION DEVICE Cianna Medical, Inc. | JAQ |
| Dec 7, 2009 | K092534 | ALATUS VAGINAL BALLOON PACKING SYSTEM Radiadyne | JAQ |
| Nov 17, 2009 | K093291 | VARIAN INTERSTITIAL TITANIUM NEEDLES Varian Medical Systems, Inc. | JAQ |
| Nov 3, 2009 | K092822 | CAPRI APPLICATOR Vivaray, Inc. | JAQ |
| Oct 8, 2009 | K092804 | MICROSELECTRON HDR V2, MODEL 105.999 Nucletron Corp. | JAQ |
| Aug 27, 2009 | K092405 | MAMMOSITE MULTI LUMEN Hologic, Inc. | JAQ |
| Aug 19, 2009 | K092323 | CONTURA CAVITY MAINTENANCE CATHETER Senorx, Inc. | JAQ |
| Aug 12, 2009 | K091230 | HDR PROSTATE TEMPLATE AND ACCESSORIES Photon Technologies Corporation | JAQ |
| Jul 2, 2009 | K091378 | MAMMOSITE II RADIATION THERAPY SYSTEM Hologic, Inc. | JAQ |
| Jun 29, 2009 | K091598 | LUMENCATH APPLICATOR SET, MODELS 189. 795, 189.796, 189.797, 189.798, LUMENCATH CATHETERS Nucletron Corp. | JAQ |
| May 18, 2009 | K091154 | UTRECHT INTERSTITIAL FLETCHER CT/MR APPLICATOR SET, MODEL 110.270, INTERSTITIAL RING CT/MR APPLICATOR SET,MODEL 110.330, Nucletron Corporation | JAQ |
| Oct 30, 2008 | K082530 | APPLICATORS FOR AFTERLOADING BRACHYTHERAPY Isodose Control B.V., NL | JAQ |
| Oct 10, 2008 | K082653 | CENTERING INTRALUMINAL APPLICATOR Varian Medical Systems, Inc. | JAQ |
| Sep 12, 2008 | K082264 | CONTURA LUMEN MARKER Senorx, Inc. | JAQ |
| Jul 22, 2008 | K081677 | SAVI APPLICATOR KIT Cianna Medical, Inc. | JAQ |
| May 28, 2008 | K080934 | VIENNA RING CT/MR APPLICATOR SET, ROUND POINT TITANIUM NEEDLE SET, TROCAR POINT TITANIUM NEEDLE SET Nucletron Corporation | JAQ |
| May 9, 2008 | K081179 | MAMMOSITE CAVITY EVALUATION DEVICE Hologic, Inc. | JAQ |
| May 2, 2008 | K081079 | CONTURA MLB SOURCE APPLICATOR FOR BRACHYTHERAPY Senorx, Inc. | JAQ |
| Apr 30, 2008 | K080791 | CONTURA MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRACHYTHERAPY, MODELS B001-45 AND B011-45 Senorx, Inc. | JAQ |
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