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 |
|---|---|---|---|
| Apr 29, 2008 | K080871 | TROCAR POINT TITANIUM NEEDLE SETS, ROUND POINT TITANIUM NEEDLE SETS Nucletron Corporation | JAQ |
| Apr 4, 2008 | K080565 | MODIFICATION TO: SAVI APPLICATOR KIT Cianna Medical, Inc. | JAQ |
| Dec 7, 2007 | K073107 | VALENCIA SKIN APPLICATOR SET, MODEL: 189.701 Nucletron Corporation | JAQ |
| Nov 16, 2007 | K073133 | INTERSTITIAL NEEDLES Varian Medical Systems, Inc. | JAQ |
| Jul 18, 2007 | K071381 | GAMMAMEDPLUS IX SERIES HDR AFTERLOADER Varian Medical Systems | JAQ |
| Jul 16, 2007 | K071467 | VARISOURCE IX HDR AFTERLOADER Varian Medical Systems, Inc. | JAQ |
| Jul 3, 2007 | K062824 | AOS UNIVERSAL CONECTING GUIDE TUBE Alpha-Omega Services, Inc. | JAQ |
| May 29, 2007 | K062823 | AOS INTERSTITIAL TEMPLATES, NEEDLES & ACCESSORIES Alpha-Omega Services, Inc. | JAQ |
| May 22, 2007 | K062826 | AOS IMPLANT TUBES, IMPLANT NEEDLES & RETAINING BOTTONS Alpha-Omega Services, Inc. | JAQ |
| May 18, 2007 | K071229 | SENORAD MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRANCHYTHERAPY Senorx, Inc. | JAQ |
| Apr 13, 2007 | K070574 | FLEXITRON Isodose Control B.V., NL | JAQ |
| Apr 4, 2007 | K070659 | BIOLUCENT APPLICATOR KIT Biolucent, Inc. | JAQ |
| Mar 1, 2007 | K063815 | VARIAN ESOPHAGUS BOUGIE APPLICATOR Varian Medical Systems | JAQ |
| Dec 26, 2006 | K063382 | HDR CT COMPATIBLE SPLIT RING APPLICATOR Mick Radio-Nuclear Instruments, Inc. | JAQ |
| Dec 22, 2006 | K063381 | CT COMPATIBLE F/S/D APPLICATORS Mick Radio-Nuclear Instruments, Inc. | JAQ |
| Nov 9, 2006 | K062241 | ADJUSTABLE MULTI-CATHETER SOURCE APPLICTOR North American Scientific, Inc. | JAQ |
| Nov 7, 2006 | K062135 | ART SHIELDED BREAST APPLICATOR Advanced Radiation Therapy, LLC | JAQ |
| Oct 20, 2006 | K062830 | BIOLUCENT APPLICATOR KIT Biolucent, Inc. | JAQ |
| Aug 17, 2006 | K061354 | MICROSELECTRON V3, MODEL 106.990 Nucletron Corporation | JAQ |
| Jul 28, 2006 | K061241 | BIOLUCENT APPLICATOR, MODEL RTA-XX Biolucent, Inc. | JAQ |
| Jul 25, 2006 | K061582 | VARISOURCE 200 HDR AFTERLOADER Varian Medical Systems, Inc. | JAQ |
| Jun 6, 2006 | K060299 | ART BRACHYTHERAPY APPLICATOR Advanced Radiation Therapy, LLC | JAQ |
| Apr 19, 2006 | K052947 | SOURCE PRODUCTION & EQUIPMENT CO, INC., MODEL M-19 IR-192 BRACHYTHERAPY SOURCE Source Production & Equipment Co., Inc. | JAQ |
| Apr 11, 2006 | K060532 | HDR 1000 PLUS WELL CHAMBER, MODEL 90008 Standard Imaging, Inc. | JAQ |
| Mar 29, 2006 | K051753 | ACCU-SOURCE Oncology Systems, Inc. | JAQ |
| Mar 10, 2006 | K060349 | PROGUIDE NEEDLE SET Nucletron Corporation | JAQ |
| Nov 9, 2005 | K052228 | SMIT SLEEVE Nucletron Corporation | JAQ |
| Nov 8, 2005 | K052595 | CRC 15ULTRA Capintec, Inc. | JAQ |
| Oct 17, 2005 | K052351 | HDR IORT SHIELDED APPLICATOR Mick Radio-Nuclear Instruments, Inc. | JAQ |
| Jul 1, 2005 | K051423 | MICK HDR INTERSTITIAL IMPLANT ACCESSORIES Mick Radio-Nuclear Instruments, Inc. | JAQ |
| Mar 24, 2005 | K041715 | INTRACAVITARY MOULD APPLICATOR SET, MODEL 189.001 Nucletron Corp. | JAQ |
| Feb 16, 2005 | K042360 | VARIAN NASOPHARYNX APPLICATOR Varian Medical Systems, Inc. | JAQ |
| Nov 3, 2004 | K042586 | BEST BREAST BRACHYTHERAPY APPLICATOR Best Medical International, Inc. | JAQ |
| Aug 26, 2004 | K041929 | MAMMOSITE II RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY Proxima Therapeutics, Inc. | JAQ |
| Aug 18, 2004 | K041933 | MICROSELECTRON PDR Nucletron Corp. | JAQ |
| Jun 18, 2004 | K040704 | MODIFICATION TO HENSCHKE HDR CERVIX APPLICATOR AND HILARIS/NORI HDR CERVIX APPLICATOR Mick Radio-Nuclear Instruments, Inc. | JAQ |
| Mar 22, 2004 | K040541 | MAMMOSOURCE HIGH DOSE RATE (HDR) REMOTE AFTERLOADER Varian Medical Systems, Inc. | JAQ |
| Feb 10, 2004 | K032067 | MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY Proxima Therapeutics, Inc. | JAQ |
| Feb 2, 2004 | K033828 | CT COMPATIBLE INTRAUTERINE SLEEVES, CAT #0311, 9406 Mick Radio-Nuclear Instruments, Inc. | JAQ |
| Dec 24, 2003 | K033371 | VARIAN INTRACAVITARY BRACHYTHERAPY APPLICATORS Varian Medical Systems | JAQ |
| Nov 26, 2003 | K031524 | GAMMAMED PLUS 3/24 HDR REMOTE AFTERLOADER Varian Medical Systems, Inc. | JAQ |
| Aug 15, 2003 | K032372 | NUCLETRON COMFORT CATHETER SYSTEM, MODEL 189.007 Nucletron Corporation | JAQ |
| Aug 7, 2003 | K031158 | SWIFT 2.0, MODEL 132.001 Nucletron Corp. | JAQ |
| Jul 15, 2003 | K031273 | AMERITEK SURE-POINT HDR NEEDLE TEMPLATE Amertek Medical, Inc. | JAQ |
| May 21, 2003 | K030558 | MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY Proxima Therapeutics, Inc. | JAQ |
| Apr 3, 2003 | K030110 | CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR Mick Radio-Nuclear Instruments, Inc. | JAQ |
| Oct 25, 2002 | K023220 | VARISOURCE BREAST TEMPLATE SYSTEM Varian Medical Systems | JAQ |
| Oct 25, 2002 | K022739 | REAL TIME HDR (220V), MODEL 132.001; REAL TIME HDR (110V), MODEL 132.002 Nucletron Corporation | JAQ |
| Sep 6, 2002 | K022635 | KUSKE BREAST APPLICATOR SET, MODEL 189.006 Nucletron Corporation | JAQ |
| May 23, 2002 | K021286 | MICROSELECTRON HDR- GENIE AFTERLOADING SYSTEM, MODEL 105.989 FOR 115VOLT DEVICES AND 105.988 FOR 230VOLT DEVICES Nucletron Corp. | JAQ |
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