Product Code: JAQ FDA class 2 21 CFR 892.5700

System, Applicator, Radionuclide, Remote-Controlled

Radiology

A remote-controlled radionuclide applicator system is used in brachytherapy to mechanically deliver and retract radioactive sources to and from treatment positions within or adjacent to tumors, protecting staff from radiation exposure during the loading and unloading process. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. The product code is JAQ, regulated under 21 CFR 892.5700, within the Radiology medical specialty. No special flags apply to this device.

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510(k)s

207

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: JAQ
Device Class: FDA class 2
Regulation Number: 892.5700
Medical Specialty: Radiology
Review Panel: RA
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 207 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K252717	MAASTRO Rectal Applicator Set	May 20, 2026	Substantially Equivalent	Varian Medical Systems
K251037	Rectal Applicator	Dec 19, 2025	Substantially Equivalent	Nucletron B.V.
K252884	Guided Aarhus Applicator Set	Nov 19, 2025	Substantially Equivalent	Varian Medical Systems
K250299	CT/ MR Tandem and Ovoid Set	May 09, 2025	Substantially Equivalent	Varian Medical Systems, Inc.
K250289	Intracavitary/Interstitial System	Apr 25, 2025	Substantially Equivalent	Varian Medical Systems
K243939	Titanium Flexible Geometry FSD Applicator Set (GM11013400)	Mar 03, 2025	Substantially Equivalent	Varian Medical Systems, Inc.
K241764	Mould Probe MR Safe	Jan 10, 2025	Substantially Equivalent	Varian Medical Systems, Inc.
K242961	Intraluminal Applicator Set	Nov 26, 2024	Substantially Equivalent	Varian Medical Systems
K243045	BRAXX Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002)	Nov 19, 2024	Substantially Equivalent	Braxx Biotech Co., Ltd.
K241853	Titanium Fletcher-Style Applicator Set Defined Geometry; Smit Cervical Sleeve	Nov 07, 2024	Substantially Equivalent	Varian Medical Systems, Inc.
K241965	Catheter Surface Flap Applicator Set (GM11011830)	Oct 29, 2024	Substantially Equivalent	Varian Medical Systems
K241386	Heyman Packing Applicator Set (GM11004580)	Aug 30, 2024	Substantially Equivalent	Varian Medical Systems, Inc.
K233628	AOS Interstitial Templates, Needles, and Accessories	Jul 10, 2024	Substantially Equivalent	Alpha-Omega Services, Inc.
K233626	AOS Marker Seeds (SMG0242-025)	Jul 02, 2024	Substantially Equivalent	Alpha-Omega Services, Inc.
K240495	Flexible Fixation Device for Gynecological Applicators (GM11001960)	May 09, 2024	Substantially Equivalent	Varian Medical Systems, Inc.
K232623	Universal Endometrial Applicator Set (GM11009840)	Apr 09, 2024	Substantially Equivalent	Varian Medical Systems, Inc.
K232949	Kelowna GYN and Crook Prostate Templates	Feb 01, 2024	Substantially Equivalent	Varian Medical Systems, Inc.
K230155	Mick Valencia Applicator Set	Aug 30, 2023	Substantially Equivalent	Mick Radio-Nuclear Instruments, Inc.
K222775	Aarhus Applicator Set	Mar 13, 2023	Substantially Equivalent	Varian Medical Systems, Inc.
K221797	BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes and Length Assessment Device	Sep 14, 2022	Substantially Equivalent	Varian Medical Systems, Inc.
K193240	Universal Cylinder Applicator Family	Aug 17, 2020	Substantially Equivalent	Varian Medical Systems, Inc.
K201272	Geneva	Jul 16, 2020	Substantially Equivalent	Nucletron B.V.
K201279	ASSISTO Universal Applicator Clamping Device	Jul 10, 2020	Substantially Equivalent	Geomed Medizin-Technik GmbH & Co. KG
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	Feb 28, 2020	Substantially Equivalent	Mick Radio-Nuclear Instruments, Inc.
K191580	BRAVOS Afterloader System, Transfer Guide Tubes, Length Assessment Device	Jul 08, 2019	Substantially Equivalent	Varian Medical Systems, Inc.
K183332	BRAXX Esophageal Brachytherapy Applicator	Apr 16, 2019	Substantially Equivalent	Braxx Biotech Co., Ltd.
K172533	GM Implant Tubes, Length Cutting Gauge	Oct 22, 2018	Substantially Equivalent	Varian Medical Systems, Inc.
K181903	BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes, and Length Assessment Device	Oct 03, 2018	Substantially Equivalent	Varian Medical Systems, Inc.
K172675	Varian Cervical Sleeves	May 16, 2018	Substantially Equivalent	Varian Medical Systems, Inc.
K180069	HDR MRI Lumen Marker	Apr 27, 2018	Substantially Equivalent	C4 Imaging, LLC
K162499	Best Instruminal Applicator	Apr 13, 2018	Substantially Equivalent	Best Medical International, Inc.
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	Mar 21, 2018	Substantially Equivalent	Varian Medical Systems, Inc.
K171631	Standard Catheter Set	Feb 09, 2018	Substantially Equivalent	Varian Medical Systems, Inc.
K162533	Kelowna GYN and Crook Prostate Templates	Aug 31, 2017	Substantially Equivalent	Varian Medical Systems, Inc.
K170203	System, Applicator, Radionuclide, Remote Controlled	Jun 01, 2017	Substantially Equivalent	Kobold, LLC
K162615	Mould Applicator Set	Mar 24, 2017	Substantially Equivalent	Varian Medical Systems, Inc.
K160815	Interstitial Needles	Mar 10, 2017	Substantially Equivalent	Varian Medical Systems, Inc.
K162018	Surface Applicator Set	Feb 28, 2017	Substantially Equivalent	Varian Medical Systems, Inc.
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	Feb 13, 2017	Substantially Equivalent	Kobold, LLC
K161688	Advanced Gynecological Applicator	Jan 27, 2017	Substantially Equivalent	Nucletron B.V.
K160045	Heyman Packing Applicator Set	Nov 17, 2016	Substantially Equivalent	Varian Medical Systems, Inc.
K161540	Advanced Breast Template System	Oct 20, 2016	Substantially Equivalent	Varian Medical Systems, Inc.
K161576	Esophagus Bougie Set	Oct 02, 2016	Substantially Equivalent	Varian Medical Systems, Inc.
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	Aug 10, 2016	Substantially Equivalent	Varian Medical Systems, Inc.
K150979	CT/MR Compatible M.A.C. Interstitial GYN Template	May 31, 2016	Substantially Equivalent	Mick Radio-Nuclear Instruments, Inc.
K160021	Varian Sterilization Boxes	Apr 13, 2016	Substantially Equivalent	Varian Medical Systems, Inc.
K151022	Intraluminal Applicator Set	Dec 17, 2015	Substantially Equivalent	Varian Medical Systems, Inc.
K152018	Varian Cleaning Caps, Varian Leak Stop Buttons, Varian Leak Stop Channel Marker Sets	Sep 11, 2015	Substantially Equivalent	Varian Medical Systems, Inc.
K151657	Shielded Applicator Set, Cervical Stop	Aug 07, 2015	Substantially Equivalent	Varian Medical Systems, Inc.
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	Jul 17, 2015	Substantially Equivalent	Varian Medical Systems, Inc.
K151272	Henschke Titanium Applicator Set	Jun 23, 2015	Substantially Equivalent	Nucletron B.V.
K142719	E-App	May 20, 2015	Substantially Equivalent	Gc Medtech, LLC
K142986	SagiNova	Apr 17, 2015	Substantially Equivalent	Eckert & Ziegler Bebig GmbH
K142330	Kobold Ring and Tandem Applicator Set	Apr 09, 2015	Substantially Equivalent	Kobold, LLC
K142439	Martinez Prostate Template Set	Mar 10, 2015	Substantially Equivalent	Nucletron B.V.
K141624	PLASTIC NEEDLE WITH MANDRIN, 2.0 MM DIAMETER, LENGTH, BLUNT TIP,PLASTIC NEEDLE WITH MANDRIN, 2.0 MM DIAMETER, LENGTH 113	Mar 10, 2015	Substantially Equivalent	Varian Medical Systems, Inc.
K142597	Vienna System	Feb 19, 2015	Substantially Equivalent	Mick Radio-Nuclear Instruments, Inc.
K141490	UNIVERSAL SEGMENTED CYLINDER APPLICATOR SET AND UNIVERSAL STUMP APPLICATOR SET	Sep 26, 2014	Substantially Equivalent	Varian Medical Systems, Inc.
K141336	SOURCE GUIDE TUBE WITH LOCKING MECHANISM FOR 113 MM NEEDLES, GAMMAMEDPLUS	Aug 06, 2014	Substantially Equivalent	Varian Medical Systems, Inc.
K140803	LUNERAY;CATHETER 6F 50CM, NEEDLE 37MM R30MM/47MM R45MM/57MM R60MM/67MM R75 MM	Jun 26, 2014	Substantially Equivalent	Nucletron B.V.
K133922	GENTLECARE AR APPLICATOR	Apr 18, 2014	Substantially Equivalent	Gc Medtech, LLC
K130757	KOBOLD SECURE LOCK TRANSFER GUIDE TUBE SET; KOBOLD LUER TRANSFER GUIDE TUBE SET	Apr 03, 2014	Substantially Equivalent	Spencer Fillmore
K132889	FLETCHER CT/MR SHIELDED APPLICATOR SET (6 MM) FLETCHER CT/MR SHIELDED APPLICATOR SET (4 MM)	Feb 26, 2014	Substantially Equivalent	Nucletron B.V.
K132874	LUMENCARE AZURE SET F6, 150CM, LUMECARE AZURE SET 5F, 150 CM, LUMENCARE AZURE SET 5F, 140 CM	Feb 21, 2014	Substantially Equivalent	Nucletron B.V.
K132097	BEST MULTI-LUMEN BALLOON APPLICATOR FOR BRACHYTHERAPY	Sep 30, 2013	Substantially Equivalent	Best Medical International, Inc.
K123912	KOBOLD FLETCHER TYPE APPLICATOR SET, KOBOLD HENSCHKE TYPE APPLICATOR SET	May 14, 2013	Substantially Equivalent	Spencer Fillmore
K123941	KOBOLD SURE-GUIDE VAGINAL CYLINDER SET, STUMP VAGINAL CYLINDER SET, MIAMI CYLINDER SET	Apr 30, 2013	Substantially Equivalent	Spencer Fillmore
K130251	ESOPHAGUS BOUGIE SET	Mar 13, 2013	Substantially Equivalent	Varian Medical Systems, Inc.
K123815	SURFACE APPLICATOR SET WITH LEIPZIG-STYLE CONE	Mar 11, 2013	Substantially Equivalent	Varian Medical Systems, Inc.
K123442	XOFT AXXENT CERVICAL APPLICATORS	Feb 27, 2013	Substantially Equivalent	Icad, Inc.
K122840	CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR MODEL 0407	Dec 14, 2012	Substantially Equivalent	Mick Radio-Nuclear Instruments, Inc.
K122236	VARISOURSE IX BRAHYTHERAPY AFTERLOADER VARISOURCE IX (T) BRACHYTHERAPY AFTERLOADER	Nov 16, 2012	Substantially Equivalent	Varian Medical Systems, Inc.
K120993	GAMMAMEDPLUS IX BRACHYTHERAPY AFTERLOADER, GAMMAMEDPLUS 3/24 IX BRACHYTHERAPY AFTERLOADER	Jul 26, 2012	Substantially Equivalent	Varian Medical Systems, Inc.
K120731	TITANIUM FLETCHER-STYLE APPLICATOR SET-DEFINED GEOMETRY	Jun 06, 2012	Substantially Equivalent	Varian Medical Systems, Inc.
K120344	RADIAPAK BRACHYTHERAPY APPLICATOR BALLOON DEVICE	May 03, 2012	Substantially Equivalent	Radiadyne, LLC (Specification Developer)
K120341	PLASTIC NEEDLE WITH MANDRIN 2.0 DIAMETER LENGTH 113MM	Apr 27, 2012	Substantially Equivalent	Varian Medical Systems, Inc.
K113766	CLICKFIT TRANSFER GUIDE TUBES NEEDLE CLICKFIT TRANSFER GUIDE TUBES CATHETER TRANSFER GUIDE TUBE SET VARISOURCE LUER TRAN	Mar 16, 2012	Substantially Equivalent	Varian Medical Systems, Inc.
K112420	ONCENTRA PROSTATE 4.0	Nov 18, 2011	Substantially Equivalent	Nucletron
K111973	VAGINAL CT / MR MULTI CHANNEL APPLICATOR SET	Sep 21, 2011	Substantially Equivalent	Nucletron
K103215	CIANNA S1, SINGLE LUMEN BALLOON APPLICATOR KIT	Nov 15, 2010	Substantially Equivalent	Cianna Medical
K101411	SAVI PREPARATION DEVICE	Jul 12, 2010	Substantially Equivalent	Cianna Medical, Inc.
K092534	ALATUS VAGINAL BALLOON PACKING SYSTEM	Dec 07, 2009	Substantially Equivalent	Radiadyne
K093291	VARIAN INTERSTITIAL TITANIUM NEEDLES	Nov 17, 2009	Substantially Equivalent	Varian Medical Systems, Inc.
K092822	CAPRI APPLICATOR	Nov 03, 2009	Substantially Equivalent	Vivaray, Inc.
K092804	MICROSELECTRON HDR V2, MODEL 105.999	Oct 08, 2009	Substantially Equivalent	Nucletron Corp.
K092405	MAMMOSITE MULTI LUMEN	Aug 27, 2009	Unknown	Hologic, Inc.
K092323	CONTURA CAVITY MAINTENANCE CATHETER	Aug 19, 2009	Substantially Equivalent	Senorx, Inc.
K091230	HDR PROSTATE TEMPLATE AND ACCESSORIES	Aug 12, 2009	Substantially Equivalent	Photon Technologies Corporation
K091378	MAMMOSITE II RADIATION THERAPY SYSTEM	Jul 02, 2009	Unknown	Hologic, Inc.
K091598	LUMENCATH APPLICATOR SET, MODELS 189. 795, 189.796, 189.797, 189.798, LUMENCATH CATHETERS	Jun 29, 2009	Substantially Equivalent	Nucletron Corp.
K091154	UTRECHT INTERSTITIAL FLETCHER CT/MR APPLICATOR SET, MODEL 110.270, INTERSTITIAL RING CT/MR APPLICATOR SET,MODEL 110.330,	May 18, 2009	Substantially Equivalent	Nucletron Corporation
K082530	APPLICATORS FOR AFTERLOADING BRACHYTHERAPY	Oct 30, 2008	Substantially Equivalent	Isodose Control B.V.
K082653	CENTERING INTRALUMINAL APPLICATOR	Oct 10, 2008	Substantially Equivalent	Varian Medical Systems, Inc.
K082264	CONTURA LUMEN MARKER	Sep 12, 2008	Unknown	Senorx, Inc.
K081677	SAVI APPLICATOR KIT	Jul 22, 2008	Unknown	Cianna Medical, Inc.
K080934	VIENNA RING CT/MR APPLICATOR SET, ROUND POINT TITANIUM NEEDLE SET, TROCAR POINT TITANIUM NEEDLE SET	May 28, 2008	Substantially Equivalent	Nucletron Corporation
K081179	MAMMOSITE CAVITY EVALUATION DEVICE	May 09, 2008	Substantially Equivalent	Hologic, Inc.
K081079	CONTURA MLB SOURCE APPLICATOR FOR BRACHYTHERAPY	May 02, 2008	Unknown	Senorx, Inc.
K080791	CONTURA MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRACHYTHERAPY, MODELS B001-45 AND B011-45	Apr 30, 2008	Unknown	Senorx, Inc.
K080871	TROCAR POINT TITANIUM NEEDLE SETS, ROUND POINT TITANIUM NEEDLE SETS	Apr 29, 2008	Substantially Equivalent	Nucletron Corporation
K080565	MODIFICATION TO: SAVI APPLICATOR KIT	Apr 04, 2008	Unknown	Cianna Medical, Inc.
K073107	VALENCIA SKIN APPLICATOR SET, MODEL: 189.701	Dec 07, 2007	Substantially Equivalent	Nucletron Corporation
K073133	INTERSTITIAL NEEDLES	Nov 16, 2007	Substantially Equivalent	Varian Medical Systems, Inc.
K071381	GAMMAMEDPLUS IX SERIES HDR AFTERLOADER	Jul 18, 2007	Substantially Equivalent	Varian Medical Systems
K071467	VARISOURCE IX HDR AFTERLOADER	Jul 16, 2007	Substantially Equivalent	Varian Medical Systems, Inc.
K062824	AOS UNIVERSAL CONECTING GUIDE TUBE	Jul 03, 2007	Substantially Equivalent	Alpha-Omega Services, Inc.
K062823	AOS INTERSTITIAL TEMPLATES, NEEDLES & ACCESSORIES	May 29, 2007	Substantially Equivalent	Alpha-Omega Services, Inc.
K062826	AOS IMPLANT TUBES, IMPLANT NEEDLES & RETAINING BOTTONS	May 22, 2007	Substantially Equivalent	Alpha-Omega Services, Inc.
K071229	SENORAD MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRANCHYTHERAPY	May 18, 2007	Unknown	Senorx, Inc.
K070574	FLEXITRON	Apr 13, 2007	Substantially Equivalent	Isodose Control B.V.
K070659	BIOLUCENT APPLICATOR KIT	Apr 04, 2007	Unknown	Biolucent, Inc.
K063815	VARIAN ESOPHAGUS BOUGIE APPLICATOR	Mar 01, 2007	Substantially Equivalent	Varian Medical Systems
K063382	HDR CT COMPATIBLE SPLIT RING APPLICATOR	Dec 26, 2006	Substantially Equivalent	Mick Radio-Nuclear Instruments, Inc.
K063381	CT COMPATIBLE F/S/D APPLICATORS	Dec 22, 2006	Substantially Equivalent	Mick Radio-Nuclear Instruments, Inc.
K062241	ADJUSTABLE MULTI-CATHETER SOURCE APPLICTOR	Nov 09, 2006	Unknown	North American Scientific, Inc.
K062135	ART SHIELDED BREAST APPLICATOR	Nov 07, 2006	Substantially Equivalent	Advanced Radiation Therapy, LLC
K062830	BIOLUCENT APPLICATOR KIT	Oct 20, 2006	Substantially Equivalent	Biolucent, Inc.
K061354	MICROSELECTRON V3, MODEL 106.990	Aug 17, 2006	Substantially Equivalent	Nucletron Corporation
K061241	BIOLUCENT APPLICATOR, MODEL RTA-XX	Jul 28, 2006	Substantially Equivalent	Biolucent, Inc.
K061582	VARISOURCE 200 HDR AFTERLOADER	Jul 25, 2006	Substantially Equivalent	Varian Medical Systems, Inc.
K060299	ART BRACHYTHERAPY APPLICATOR	Jun 06, 2006	Substantially Equivalent	Advanced Radiation Therapy, LLC
K052947	SOURCE PRODUCTION & EQUIPMENT CO, INC., MODEL M-19 IR-192 BRACHYTHERAPY SOURCE	Apr 19, 2006	Substantially Equivalent	Source Production & Equipment Co., Inc.
K060532	HDR 1000 PLUS WELL CHAMBER, MODEL 90008	Apr 11, 2006	Substantially Equivalent	Standard Imaging, Inc.
K051753	ACCU-SOURCE	Mar 29, 2006	Substantially Equivalent	Oncology Systems, Inc.
K060349	PROGUIDE NEEDLE SET	Mar 10, 2006	Substantially Equivalent	Nucletron Corporation
K052228	SMIT SLEEVE	Nov 09, 2005	Substantially Equivalent	Nucletron Corporation
K052595	CRC 15ULTRA	Nov 08, 2005	Substantially Equivalent	Capintec, Inc.
K052351	HDR IORT SHIELDED APPLICATOR	Oct 17, 2005	Substantially Equivalent	Mick Radio-Nuclear Instruments, Inc.
K051423	MICK HDR INTERSTITIAL IMPLANT ACCESSORIES	Jul 01, 2005	Substantially Equivalent	Mick Radio-Nuclear Instruments, Inc.
K041715	INTRACAVITARY MOULD APPLICATOR SET, MODEL 189.001	Mar 24, 2005	Substantially Equivalent	Nucletron Corp.
K042360	VARIAN NASOPHARYNX APPLICATOR	Feb 16, 2005	Substantially Equivalent	Varian Medical Systems, Inc.
K042586	BEST BREAST BRACHYTHERAPY APPLICATOR	Nov 03, 2004	Substantially Equivalent	Best Medical International, Inc.
K041929	MAMMOSITE II RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY	Aug 26, 2004	Substantially Equivalent	Proxima Therapeutics, Inc.
K041933	MICROSELECTRON PDR	Aug 18, 2004	Substantially Equivalent	Nucletron Corp.
K040704	MODIFICATION TO HENSCHKE HDR CERVIX APPLICATOR AND HILARIS/NORI HDR CERVIX APPLICATOR	Jun 18, 2004	Substantially Equivalent	Mick Radio-Nuclear Instruments, Inc.
K040541	MAMMOSOURCE HIGH DOSE RATE (HDR) REMOTE AFTERLOADER	Mar 22, 2004	Substantially Equivalent	Varian Medical Systems, Inc.
K032067	MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY	Feb 10, 2004	Substantially Equivalent	Proxima Therapeutics, Inc.
K033828	CT COMPATIBLE INTRAUTERINE SLEEVES, CAT #0311, 9406	Feb 02, 2004	Substantially Equivalent	Mick Radio-Nuclear Instruments, Inc.
K033371	VARIAN INTRACAVITARY BRACHYTHERAPY APPLICATORS	Dec 24, 2003	Substantially Equivalent	Varian Medical Systems
K031524	GAMMAMED PLUS 3/24 HDR REMOTE AFTERLOADER	Nov 26, 2003	Substantially Equivalent	Varian Medical Systems, Inc.
K032372	NUCLETRON COMFORT CATHETER SYSTEM, MODEL 189.007	Aug 15, 2003	Substantially Equivalent	Nucletron Corporation
K031158	SWIFT 2.0, MODEL 132.001	Aug 07, 2003	Substantially Equivalent	Nucletron Corp.
K031273	AMERITEK SURE-POINT HDR NEEDLE TEMPLATE	Jul 15, 2003	Substantially Equivalent	Amertek Medical, Inc.
K030558	MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY	May 21, 2003	Substantially Equivalent	Proxima Therapeutics, Inc.
K030110	CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR	Apr 03, 2003	Substantially Equivalent	Mick Radio-Nuclear Instruments, Inc.
K023220	VARISOURCE BREAST TEMPLATE SYSTEM	Oct 25, 2002	Substantially Equivalent	Varian Medical Systems
K022739	REAL TIME HDR (220V), MODEL 132.001; REAL TIME HDR (110V), MODEL 132.002	Oct 25, 2002	Substantially Equivalent	Nucletron Corporation
K022635	KUSKE BREAST APPLICATOR SET, MODEL 189.006	Sep 06, 2002	Substantially Equivalent	Nucletron Corporation
K021286	MICROSELECTRON HDR- GENIE AFTERLOADING SYSTEM, MODEL 105.989 FOR 115VOLT DEVICES AND 105.988 FOR 230VOLT DEVICES	May 23, 2002	Substantially Equivalent	Nucletron Corp.
K011690	MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY	May 06, 2002	Unknown	Proxima Therapeutics, Inc.
K020176	HDR MIAMI APPLICATOR	Apr 08, 2002	Substantially Equivalent	Mick Radio-Nuclear Instruments, Inc.
K020015	IMPLANT GUIDANCE SYSTEM APPLICATOR SET	Mar 13, 2002	Substantially Equivalent	Nucletron Corp.
K010032	SEED SELECTRON MODEL V. 1.0	Oct 17, 2001	Substantially Equivalent	Nucletron Corp.
K011657	HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR	Aug 27, 2001	Substantially Equivalent	Mick Radio-Nuclear Instruments, Inc.
K003270	PROSTATE STEPPER TEMPLATE SET, MODEL PART NUMBER 189,065,189,066,189,067	Dec 22, 2000	Substantially Equivalent	Nucletron Corp.
K000081	MANUAL AND REMOTE CONTROLLED APPLICATOR SYSTEM	Dec 19, 2000	Substantially Equivalent	Isotopes and Metals , Ltd.
K001544	VAGINAL APPLICATOR SHIELDED	Nov 17, 2000	Substantially Equivalent	Mick Radio-Nuclear Instruments, Inc.
K001825	STANDARD IMAGING HDR 1000 PLUS ION CHAMBER; STANDARD IMAGING IVB 1000 ION CHAMBER	Aug 02, 2000	Substantially Equivalent	Standard Imaging, Inc.
K993472	SEGMENTED VAGINAL APPLICATOR	Jan 12, 2000	Substantially Equivalent	Mick Radio-Nuclear Instruments, Inc.
K993400	HDR CONTOUR TP TEMPLATE AND IMPLANT ACCESSORIES	Jan 06, 2000	Substantially Equivalent	Mick Radio-Nuclear Instruments, Inc.
K990990	CET PROSTATE APPLICATOR SET, PART NUMBER 089.066	Oct 07, 1999	Substantially Equivalent	Nucletron Corp.
K990753	GRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER	May 27, 1999	Substantially Equivalent	Cook, Inc.
K983338	FREIBURG FLAP APPLICATOR SET, PART NUMBER 089.095	Apr 20, 1999	Substantially Equivalent	Nucletron Corp.
K983341	STANDARD CT/MR APPLICATOR SET,RING CT/MR APPLICATOR SET, VAGINAL CT/MR APPLICATOR SET, FLETCHER WILLIAMSON APPLICATOR SE	Apr 15, 1999	Substantially Equivalent	Nucletron Corp.
K983337	ROTTERDAM NASOPHAYRNX MOULD SET, PART #089.068	Apr 02, 1999	Substantially Equivalent	Nucletron Corp.
K983115	TREATMENT CONTROL STATION - MICROSELECTRON-HDR CLASSIC UPGRADE, VERSION 1.20	Apr 02, 1999	Substantially Equivalent	Nucletron Corp.
K981886	VRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER	Nov 03, 1998	Substantially Equivalent	Cook, Inc.
K980576	VARIAN ENDOMETRIAL APPLICATOR FOR VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER	Nov 02, 1998	Substantially Equivalent	Varian Medical Systems, Inc.
K983436	GAMMAMED PLUS HIGH DOSE RATE REMOTE AFTERLOADING SYSTEM	Oct 29, 1998	Substantially Equivalent	Gammamed USA
K980590	VARISOURCE HENSCHKE TYPE GYN APPLICATOR FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER	Oct 22, 1998	Substantially Equivalent	Varian Medical Systems, Inc.
K980601	VARISOURCE WRIGHT VAGINAL CUFF APPLICATOR FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERIOADER	Oct 21, 1998	Substantially Equivalent	Varian Assoc., Inc.
K964910	AOS UNIVERSAL CONNECTING GUIDE TUBE FOR HIGH DOSE RATE AFTERLOADERS	Mar 10, 1997	Substantially Equivalent	Alpha-Omega Services, Inc.
K961601	H.A.M. APPLICATOR	Dec 23, 1996	Substantially Equivalent	Mick Radio-Nuclear Instruments, Inc.
K953946	MICROSELECTRON-HDR VERSION 2	Aug 13, 1996	Substantially Equivalent	Nucletron-Oldelft Corp.
K955844	APPLICATORS FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER	Jul 26, 1996	Substantially Equivalent	Varian Assoc., Inc.
K954467	CADPLAN BT	Mar 15, 1996	Substantially Equivalent	Varian Assoc., Inc.
K952913	APPLICATORS FOR VARIAN VARISOURCE REMOTE HIGH SOES RATE AFTERLOADER	Nov 22, 1995	Substantially Equivalent	Varian Assoc., Inc.
K945383	HIGH DOSE RATE AFTERLOADER	Feb 15, 1995	Substantially Equivalent	Varian Assoc., Inc.
K943109	REMOTE CONTROL RADIOISOTOPE APPLICATOR	Feb 09, 1995	Substantially Equivalent	Inter-Pal GmbH
K925956	MICROSELECTRON - HDR FOR MOBILE ENVIRONMENT	Nov 19, 1993	Substantially Equivalent	Nucletron-Oldelft Corp.
K923738	HIGH DOSE RATE REMOTE AFTERLOADING CATHETER	Apr 13, 1993	Substantially Equivalent	Cook, Inc.
K922564	6 FRENCH CATHETER	Dec 17, 1992	Substantially Equivalent	S. and H. Engineering, Inc.
K901615	PULMOCATH INTRABRONCHIAL CATHETER	Nov 27, 1992	Substantially Equivalent	Omnitron Intl., Inc.
K915622	PLATO BRACHYTHERAPHY TREATMENT PLANNING SYSTEM	Sep 25, 1992	Substantially Equivalent	Nucletron-Oldelft Corp.
K922554	STANDARD IMAGING HDR 1000 ION CHAMBER	Aug 24, 1992	Substantially Equivalent	Standard Imaging, Inc.
K920431	OMNITRON NEEDLE APPLICATORS 18 AND 21 GAUGE	May 29, 1992	Substantially Equivalent	Omnitron Intl., Inc.
K915367	HDRS-1 SYSTEM	Apr 06, 1992	Substantially Equivalent	Precision Radiation Measurement, Inc.
K913908	OMNITRON GYN APPLICATOR SYSTEM	Mar 06, 1992	Substantially Equivalent	Omnitron Intl., Inc.
K914578	RTS TECHNOLOGY MODELS 721,722,723,724	Feb 28, 1992	Substantially Equivalent	Rts Technology, Inc.
K912555	GAMMAMED 12IT HIGH DOSE RATE REMOTE AFTERLOADER	Aug 02, 1991	Substantially Equivalent	Rts Technology, Inc.
K902533	PULSED SELECTRON	Oct 12, 1990	Substantially Equivalent	Nucletron-Oldelft Corp.
K901589	RTS TECHNOLOGY IRIDIUM 192 SOURCES	Aug 17, 1990	Substantially Equivalent	Rts Technology, Inc.
K890294	INTER-PAL C-19 AND INTER-PAL C-38	Feb 01, 1990	Substantially Equivalent	Enrad Corp.
K894381	GAMMAMED IRIDIUM-192 SOURCE	Nov 21, 1989	Substantially Equivalent	Mick Radio-Nuclear Instruments, Inc.
K890799	CURIETRON 192 HIGH DOSE RATE	Oct 27, 1989	Substantially Equivalent	Cis-Us, Inc.
K891131	GAMMAMED 12I	Aug 07, 1989	Substantially Equivalent	Mick Radio-Nuclear Instruments, Inc.
K881323	CURIETRON 192 LOW DOSE RATE	Jan 17, 1989	Substantially Equivalent	Compagnie Oris Industrie, S.A.
K881665	OMNITRON REMOTE CONTROLLED RADIONUCLIDE APPLICATOR	Aug 11, 1988	Substantially Equivalent	Omnitron Intl., Inc.
K864210	MICROSELECTRON-HDR (HIGH DOSE RATE)	Nov 26, 1986	Substantially Equivalent	Nucletron-Oldelft Corp.
K853912	MICROSELECTION INTERSTITIAL REMOTE AFTERLOAD SYS	May 21, 1986	Substantially Equivalent	Nucletron-Oldelft Corp.
K852842	SELECTRON HDR REMOTE AFTERLOADER	Jan 10, 1986	Substantially Equivalent	Nucletron-Oldelft Corp.
K844714	SELECTRON LDR SELECTRON LOW DOSE RATE	Feb 26, 1985	Substantially Equivalent	Radiochemical Co.
K840127	CURIETRON	Mar 19, 1984	Substantially Equivalent	Syncor Intl. Corp.
K834308	MULTITREAT 48	Jan 10, 1984	Substantially Equivalent	Mick Radio-Nuclear Instruments, Inc.
K832789	AFTER LOADING BUCHLER	Sep 29, 1983	Substantially Equivalent	Ellis Pharmaceutical Consulting, Inc.
K810051	SELECTRON REMOTE ISOTOPE	Feb 02, 1981	Substantially Equivalent	Victoreen, Inc.
K781274	GAMMA MED II	Aug 10, 1978	Substantially Equivalent	Mick Radio-Nuclear Instruments, Inc.