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 2 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K080871 | TROCAR POINT TITANIUM NEEDLE SETS, ROUND POINT TITANIUM NEEDLE SETS | Nucletron Corporation | 2008-04-29 | Special | PDF ↗ |
| K080565 | MODIFICATION TO: SAVI APPLICATOR KIT | Cianna Medical, Inc. | 2008-04-04 | Special | PDF ↗ |
| K073107 | VALENCIA SKIN APPLICATOR SET, MODEL: 189.701 | Nucletron Corporation | 2007-12-07 | Special | PDF ↗ |
| K073133 | INTERSTITIAL NEEDLES | Varian Medical Systems, Inc. | 2007-11-16 | Special | PDF ↗ |
| K071381 | GAMMAMEDPLUS IX SERIES HDR AFTERLOADER | Varian Medical Systems | 2007-07-18 | Traditional | PDF ↗ |
| K071467 | VARISOURCE IX HDR AFTERLOADER | Varian Medical Systems, Inc. | 2007-07-16 | Traditional | PDF ↗ |
| K062824 | AOS UNIVERSAL CONECTING GUIDE TUBE | Alpha-Omega Services, Inc. | 2007-07-03 | Traditional | PDF ↗ |
| K062823 | AOS INTERSTITIAL TEMPLATES, NEEDLES & ACCESSORIES | Alpha-Omega Services, Inc. | 2007-05-29 | Traditional | PDF ↗ |
| K062826 | AOS IMPLANT TUBES, IMPLANT NEEDLES & RETAINING BOTTONS | Alpha-Omega Services, Inc. | 2007-05-22 | Traditional | PDF ↗ |
| K071229 | SENORAD MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRANCHYTHERAPY | Senorx, Inc. | 2007-05-18 | Traditional | PDF ↗ |
| K070574 | FLEXITRON | Isodose Control B.V. | 2007-04-13 | Abbreviated | PDF ↗ |
| K070659 | BIOLUCENT APPLICATOR KIT | Biolucent, Inc. | 2007-04-04 | Special | PDF ↗ |
| K063815 | VARIAN ESOPHAGUS BOUGIE APPLICATOR | Varian Medical Systems | 2007-03-01 | Traditional | PDF ↗ |
| K063382 | HDR CT COMPATIBLE SPLIT RING APPLICATOR | Mick Radio-Nuclear Instruments, Inc. | 2006-12-26 | Traditional | PDF ↗ |
| K063381 | CT COMPATIBLE F/S/D APPLICATORS | Mick Radio-Nuclear Instruments, Inc. | 2006-12-22 | Traditional | PDF ↗ |
| K062241 | ADJUSTABLE MULTI-CATHETER SOURCE APPLICTOR | North American Scientific, Inc. | 2006-11-09 | Traditional | PDF ↗ |
| K062135 | ART SHIELDED BREAST APPLICATOR | Advanced Radiation Therapy, LLC | 2006-11-07 | Traditional | PDF ↗ |
| K062830 | BIOLUCENT APPLICATOR KIT | Biolucent, Inc. | 2006-10-20 | Special | PDF ↗ |
| K061354 | MICROSELECTRON V3, MODEL 106.990 | Nucletron Corporation | 2006-08-17 | Special | PDF ↗ |
| K061241 | BIOLUCENT APPLICATOR, MODEL RTA-XX | Biolucent, Inc. | 2006-07-28 | Traditional | PDF ↗ |
| K061582 | VARISOURCE 200 HDR AFTERLOADER | Varian Medical Systems, Inc. | 2006-07-25 | Traditional | PDF ↗ |
| K060299 | ART BRACHYTHERAPY APPLICATOR | Advanced Radiation Therapy, LLC | 2006-06-06 | Traditional | PDF ↗ |
| K052947 | SOURCE PRODUCTION & EQUIPMENT CO, INC., MODEL M-19 IR-192 BRACHYTHERAPY SOURCE | Source Production & Equipment Co., Inc. | 2006-04-19 | Traditional | PDF ↗ |
| K060532 | HDR 1000 PLUS WELL CHAMBER, MODEL 90008 | Standard Imaging, Inc. | 2006-04-11 | Traditional | PDF ↗ |
| K051753 | ACCU-SOURCE | Oncology Systems, Inc. | 2006-03-29 | Traditional | PDF ↗ |
| K060349 | PROGUIDE NEEDLE SET | Nucletron Corporation | 2006-03-10 | Special | PDF ↗ |
| K052228 | SMIT SLEEVE | Nucletron Corporation | 2005-11-09 | Traditional | PDF ↗ |
| K052595 | CRC 15ULTRA | Capintec, Inc. | 2005-11-08 | Traditional | PDF ↗ |
| K052351 | HDR IORT SHIELDED APPLICATOR | Mick Radio-Nuclear Instruments, Inc. | 2005-10-17 | Traditional | PDF ↗ |
| K051423 | MICK HDR INTERSTITIAL IMPLANT ACCESSORIES | Mick Radio-Nuclear Instruments, Inc. | 2005-07-01 | Traditional | PDF ↗ |
| K041715 | INTRACAVITARY MOULD APPLICATOR SET, MODEL 189.001 | Nucletron Corp. | 2005-03-24 | Traditional | PDF ↗ |
| K042360 | VARIAN NASOPHARYNX APPLICATOR | Varian Medical Systems, Inc. | 2005-02-16 | Traditional | PDF ↗ |
| K042586 | BEST BREAST BRACHYTHERAPY APPLICATOR | Best Medical International, Inc. | 2004-11-03 | Traditional | PDF ↗ |
| K041929 | MAMMOSITE II RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY | Proxima Therapeutics, Inc. | 2004-08-26 | Special | PDF ↗ |
| K041933 | MICROSELECTRON PDR | Nucletron Corp. | 2004-08-18 | Special | PDF ↗ |
| K040704 | MODIFICATION TO HENSCHKE HDR CERVIX APPLICATOR AND HILARIS/NORI HDR CERVIX APPLICATOR | Mick Radio-Nuclear Instruments, Inc. | 2004-06-18 | Traditional | PDF ↗ |
| K040541 | MAMMOSOURCE HIGH DOSE RATE (HDR) REMOTE AFTERLOADER | Varian Medical Systems, Inc. | 2004-03-22 | Special | PDF ↗ |
| K032067 | MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY | Proxima Therapeutics, Inc. | 2004-02-10 | Traditional | PDF ↗ |
| K033828 | CT COMPATIBLE INTRAUTERINE SLEEVES, CAT #0311, 9406 | Mick Radio-Nuclear Instruments, Inc. | 2004-02-02 | Traditional | PDF ↗ |
| K033371 | VARIAN INTRACAVITARY BRACHYTHERAPY APPLICATORS | Varian Medical Systems | 2003-12-24 | Traditional | PDF ↗ |
| K031524 | GAMMAMED PLUS 3/24 HDR REMOTE AFTERLOADER | Varian Medical Systems, Inc. | 2003-11-26 | Traditional | PDF ↗ |
| K032372 | NUCLETRON COMFORT CATHETER SYSTEM, MODEL 189.007 | Nucletron Corporation | 2003-08-15 | Traditional | PDF ↗ |
| K031158 | SWIFT 2.0, MODEL 132.001 | Nucletron Corp. | 2003-08-07 | Special | PDF ↗ |
| K031273 | AMERITEK SURE-POINT HDR NEEDLE TEMPLATE | Amertek Medical, Inc. | 2003-07-15 | Traditional | PDF ↗ |
| K030558 | MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY | Proxima Therapeutics, Inc. | 2003-05-21 | Traditional | PDF ↗ |
| K030110 | CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR | Mick Radio-Nuclear Instruments, Inc. | 2003-04-03 | Traditional | PDF ↗ |
| K022739 | REAL TIME HDR (220V), MODEL 132.001; REAL TIME HDR (110V), MODEL 132.002 | Nucletron Corporation | 2002-10-25 | Special | PDF ↗ |
| K023220 | VARISOURCE BREAST TEMPLATE SYSTEM | Varian Medical Systems | 2002-10-25 | Special | PDF ↗ |
| K022635 | KUSKE BREAST APPLICATOR SET, MODEL 189.006 | Nucletron Corporation | 2002-09-06 | Special | PDF ↗ |
| K021286 | MICROSELECTRON HDR- GENIE AFTERLOADING SYSTEM, MODEL 105.989 FOR 115VOLT DEVICES AND 105.988 FOR 230VOLT DEVICES | Nucletron Corp. | 2002-05-23 | Special | PDF ↗ |
| K011690 | MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY | Proxima Therapeutics, Inc. | 2002-05-06 | Traditional | PDF ↗ |
| K020176 | HDR MIAMI APPLICATOR | Mick Radio-Nuclear Instruments, Inc. | 2002-04-08 | Traditional | PDF ↗ |
| K020015 | IMPLANT GUIDANCE SYSTEM APPLICATOR SET | Nucletron Corp. | 2002-03-13 | Special | PDF ↗ |
| K010032 | SEED SELECTRON MODEL V. 1.0 | Nucletron Corp. | 2001-10-17 | Traditional | PDF ↗ |
| K011657 | HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR | Mick Radio-Nuclear Instruments, Inc. | 2001-08-27 | Traditional | PDF ↗ |
| K003270 | PROSTATE STEPPER TEMPLATE SET, MODEL PART NUMBER 189,065,189,066,189,067 | Nucletron Corp. | 2000-12-22 | Special | PDF ↗ |
| K000081 | MANUAL AND REMOTE CONTROLLED APPLICATOR SYSTEM | Isotopes and Metals , Ltd. | 2000-12-19 | Traditional | PDF ↗ |
| K001544 | VAGINAL APPLICATOR SHIELDED | Mick Radio-Nuclear Instruments, Inc. | 2000-11-17 | Traditional | PDF ↗ |
| K001825 | STANDARD IMAGING HDR 1000 PLUS ION CHAMBER; STANDARD IMAGING IVB 1000 ION CHAMBER | Standard Imaging, Inc. | 2000-08-02 | Special | PDF ↗ |
| K993472 | SEGMENTED VAGINAL APPLICATOR | Mick Radio-Nuclear Instruments, Inc. | 2000-01-12 | Traditional | PDF ↗ |
| K993400 | HDR CONTOUR TP TEMPLATE AND IMPLANT ACCESSORIES | Mick Radio-Nuclear Instruments, Inc. | 2000-01-06 | Traditional | PDF ↗ |
| K990990 | CET PROSTATE APPLICATOR SET, PART NUMBER 089.066 | Nucletron Corp. | 1999-10-07 | Traditional | PDF ↗ |
| K990753 | GRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER | Cook, Inc. | 1999-05-27 | Traditional | PDF ↗ |
| K983338 | FREIBURG FLAP APPLICATOR SET, PART NUMBER 089.095 | Nucletron Corp. | 1999-04-20 | Traditional | PDF ↗ |
| K983341 | STANDARD CT/MR APPLICATOR SET,RING CT/MR APPLICATOR SET, VAGINAL CT/MR APPLICATOR SET, FLETCHER WILLIAMSON APPLICATOR SE | Nucletron Corp. | 1999-04-15 | Traditional | PDF ↗ |
| K983115 | TREATMENT CONTROL STATION - MICROSELECTRON-HDR CLASSIC UPGRADE, VERSION 1.20 | Nucletron Corp. | 1999-04-02 | Traditional | PDF ↗ |
| K983337 | ROTTERDAM NASOPHAYRNX MOULD SET, PART #089.068 | Nucletron Corp. | 1999-04-02 | Traditional | PDF ↗ |
| K981886 | VRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER | Cook, Inc. | 1998-11-03 | Traditional | PDF ↗ |
| K980576 | VARIAN ENDOMETRIAL APPLICATOR FOR VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER | Varian Medical Systems, Inc. | 1998-11-02 | Traditional | PDF ↗ |
| K983436 | GAMMAMED PLUS HIGH DOSE RATE REMOTE AFTERLOADING SYSTEM | Gammamed USA | 1998-10-29 | Special | PDF ↗ |
| K980590 | VARISOURCE HENSCHKE TYPE GYN APPLICATOR FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER | Varian Medical Systems, Inc. | 1998-10-22 | Traditional | PDF ↗ |
| K980601 | VARISOURCE WRIGHT VAGINAL CUFF APPLICATOR FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERIOADER | Varian Assoc., Inc. | 1998-10-21 | Traditional | PDF ↗ |
| K964910 | AOS UNIVERSAL CONNECTING GUIDE TUBE FOR HIGH DOSE RATE AFTERLOADERS | Alpha-Omega Services, Inc. | 1997-03-10 | Traditional | PDF ↗ |
| K961601 | H.A.M. APPLICATOR | Mick Radio-Nuclear Instruments, Inc. | 1996-12-23 | Traditional | PDF ↗ |
| K953946 | MICROSELECTRON-HDR VERSION 2 | Nucletron-Oldelft Corp. | 1996-08-13 | Traditional | PDF ↗ |
| K955844 | APPLICATORS FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER | Varian Assoc., Inc. | 1996-07-26 | Traditional | PDF ↗ |
| K954467 | CADPLAN BT | Varian Assoc., Inc. | 1996-03-15 | Traditional | PDF ↗ |
| K952913 | APPLICATORS FOR VARIAN VARISOURCE REMOTE HIGH SOES RATE AFTERLOADER | Varian Assoc., Inc. | 1995-11-22 | Traditional | PDF ↗ |
| K945383 | HIGH DOSE RATE AFTERLOADER | Varian Assoc., Inc. | 1995-02-15 | Traditional | PDF ↗ |
| K943109 | REMOTE CONTROL RADIOISOTOPE APPLICATOR | Inter-Pal GmbH | 1995-02-09 | Traditional | PDF ↗ |
| K925956 | MICROSELECTRON - HDR FOR MOBILE ENVIRONMENT | Nucletron-Oldelft Corp. | 1993-11-19 | Traditional | PDF ↗ |
| K923738 | HIGH DOSE RATE REMOTE AFTERLOADING CATHETER | Cook, Inc. | 1993-04-13 | Traditional | PDF ↗ |
| K922564 | 6 FRENCH CATHETER | S. and H. Engineering, Inc. | 1992-12-17 | Traditional | PDF ↗ |
| K901615 | PULMOCATH INTRABRONCHIAL CATHETER | Omnitron Intl., Inc. | 1992-11-27 | Traditional | PDF ↗ |
| K915622 | PLATO BRACHYTHERAPHY TREATMENT PLANNING SYSTEM | Nucletron-Oldelft Corp. | 1992-09-25 | Traditional | PDF ↗ |
| K922554 | STANDARD IMAGING HDR 1000 ION CHAMBER | Standard Imaging, Inc. | 1992-08-24 | Traditional | PDF ↗ |
| K920431 | OMNITRON NEEDLE APPLICATORS 18 AND 21 GAUGE | Omnitron Intl., Inc. | 1992-05-29 | Traditional | PDF ↗ |
| K915367 | HDRS-1 SYSTEM | Precision Radiation Measurement, Inc. | 1992-04-06 | Traditional | PDF ↗ |
| K913908 | OMNITRON GYN APPLICATOR SYSTEM | Omnitron Intl., Inc. | 1992-03-06 | Traditional | PDF ↗ |
| K914578 | RTS TECHNOLOGY MODELS 721,722,723,724 | Rts Technology, Inc. | 1992-02-28 | Traditional | PDF ↗ |
| K912555 | GAMMAMED 12IT HIGH DOSE RATE REMOTE AFTERLOADER | Rts Technology, Inc. | 1991-08-02 | Traditional | PDF ↗ |
| K902533 | PULSED SELECTRON | Nucletron-Oldelft Corp. | 1990-10-12 | Traditional | PDF ↗ |
| K901589 | RTS TECHNOLOGY IRIDIUM 192 SOURCES | Rts Technology, Inc. | 1990-08-17 | Traditional | PDF ↗ |
| K890294 | INTER-PAL C-19 AND INTER-PAL C-38 | Enrad Corp. | 1990-02-01 | Traditional | PDF ↗ |
| K894381 | GAMMAMED IRIDIUM-192 SOURCE | Mick Radio-Nuclear Instruments, Inc. | 1989-11-21 | Traditional | PDF ↗ |
| K890799 | CURIETRON 192 HIGH DOSE RATE | Cis-Us, Inc. | 1989-10-27 | Traditional | PDF ↗ |
| K891131 | GAMMAMED 12I | Mick Radio-Nuclear Instruments, Inc. | 1989-08-07 | Traditional | PDF ↗ |
| K881323 | CURIETRON 192 LOW DOSE RATE | Compagnie Oris Industrie, S.A. | 1989-01-17 | Traditional | PDF ↗ |
| K881665 | OMNITRON REMOTE CONTROLLED RADIONUCLIDE APPLICATOR | Omnitron Intl., Inc. | 1988-08-11 | Traditional | PDF ↗ |
| K864210 | MICROSELECTRON-HDR (HIGH DOSE RATE) | Nucletron-Oldelft Corp. | 1986-11-26 | Traditional | PDF ↗ |
Product code JAQ · Class II · Radiology. Data: openFDA.