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
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 9, 2026 | Elekta, Inc. Brand Name: Geneva
Product Name: Brachytherapy Applicator
Product Description: The device is intended for intracavitary brachytherapy for cancer treatment of the cervix and the endometrium. Optional n Open, Classified |
JAQ | K201272 |
| Jul 9, 2026 | Elekta, Inc. Brand Name: Brachytherapy Applicator
Product Name: Advanced Gynecological Applicator
Product Description: The intended use of the Advanced Gynecological Applicator is intracavitary brachytherapy for c Open, Classified |
JAQ | K161688 |
| Jul 9, 2026 | Elekta, Inc. Brand Name: Fletcher CT/MR Shielded Applicator Set
Product Name: Intracavitary Remote Afterloading Applicator
Product Description: The Fletcher CT/MR Shielded Applicator Set is intended for gynecologi Open, Classified |
JAQ | K132889 |
| Nov 18, 2019 | Nucletron BV There is a complaint regarding internal check cable guide mechanism failure for the Nucletron Flexitron brachytherapy afterloader system. Due to an obstruction during the check cable out drive, the in Terminated |
JAQ | K070574 |
| Jun 26, 2015 | Varian Medical Systems Inc The VariSource iX series afterloader systems are computer controlled remote electro/mechanical systems used for medical purposes, for placing a cable incorporating an irradiated iridium seed internall Terminated |
JAQ | K122236 |
| Jun 23, 2015 | Varian Medical Systems Inc Surface Applicator Set with Leipzig-style Cone.
Brachytherapy applicator set. Terminated |
JAQ | K123815 |
| Oct 24, 2013 | Varian Medical Systems, Inc. VARISOURCE Breast Template System for high-dose rate Brachytherapy.
***INSTRUCTIONS FOR USE*** Breast Bridge & Template System AL13011000 ***Manufacturer: Varian Medical Systems, Inc., 3100 Hansen W Terminated |
JAQ | K023220 |
| May 15, 2013 | Varian Medical Systems, Inc. Segmented Cylinder Applicator Set, Model # GM11004150, when used for Pulsed Dose Rate (PDR)
Product Usage: Usage:
Used during pulsed dose rate brachytherapy to treat vaginal and rectal cancer. Terminated |
JAQ | None listed |
| Jan 31, 2013 | Varian Medical Systems, Inc. Rectal Retractors, titanium, item # AL07368000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachytherapy. Terminated |
JAQ | K011657 |
| Jan 31, 2013 | Varian Medical Systems, Inc. Rectal Retractors, stainless steel, item # AL07289000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachytherapy. Terminated |
JAQ | K011657 |
| Dec 20, 2012 | Varian Medical Systems, Inc. Segmented Cervix Applicator Set, part number GM11004310, a component used with the tube for segments and cervical sleeves
The guide tube for segments and cervical sleeves in the Segmented Cervix Appl Terminated |
JAQ | K983436 |
| Mar 12, 2012 | Varian Medical Systems, Inc. Nucletron Adapter and Transfer Guide Tube Set, part number AL 13005001, set of 3 adapters, components used with the VariSource" IX HDR Afterloader.
Product Usage: The adapter is part of the VariSour Terminated |
JAQ | K071467 |
| Mar 12, 2012 | Varian Medical Systems, Inc. Nucletron Adapter and Transfer Guide Tube, part number AL 13005000, a component used with the VariSource" IX HDR Afterloader.
Product Usage: The adapter is part of the VariSource Afterloader System, Terminated |
JAQ | K071467 |
| Dec 1, 2011 | Varian Medical Systems, Inc. Oncology Systems Varian brand GammaMed 12i Accessory: Clamping adapters for bronchial catheters, 1.8mm diameter, GammaMed 12i; Ref: BT-00264, Model 2-H63; Product is distributed by Varian Medical Systems Inc., Palo Al Terminated |
JAQ | K891131 |
| Dec 1, 2011 | Varian Medical Systems, Inc. Oncology Systems Varian brand GammaMed 12i Accessory: Clamping adapters for bronchial catheters, 1.8mm diameter, GammaMed 12i; Ref: BT-00264, Model 1-H63; Product is distributed by Varian Medical Systems Inc., Palo Al Terminated |
JAQ | K891131 |
| Dec 1, 2011 | Varian Medical Systems, Inc. VariSource iX, Software Version 1.1, Part Number AL20020000 VariSource iX Afterloader.
The VariSource iX Series High Dose Rate Afterloader system is a computer controlled remote electra/mechanical sy Terminated |
JAQ | K071467 |
| Dec 1, 2011 | Varian Medical Systems, Inc. GammaMed Plastic Needle with Mandrin; 2.0 mm diameter, length 320 mm. Remote controlled radionuclide applicator system. Varian Medical Systems, Inc. Mfg by Varian Medical Systems Haan GmbH, Haan, Germ Terminated |
JAQ | K983436 |
| Dec 1, 2011 | Varian Medical Systems, Inc. GammaMed Plastic Needle with Mandrin; 2.0 mm diameter, length 200 mm. Remote controlled radionuclide applicator system. Varian Medical Systems, Inc. Mfg by Varian Medical Systems Haan GmbH, Haan, Germ Terminated |
JAQ | K983436 |
| Dec 1, 2011 | Varian Medical Systems, Inc. GammaMed Plastic Needle with Mandrin; 2.0 mm diameter, length 113 mm. Remote controlled radionuclide applicator system. Varian Medical Systems, Inc. Mfg by Varian Medical Systems Haan GmbH, Haan, Germ Terminated |
JAQ | K983436 |
| Nov 30, 2011 | Varian Medical Systems, Inc. GammaMed Flexible Applicator Probe, Part GM11002560 - 3.2 mm diameter braced PVDF. Varian Medical Systems, Palo Alto, CA, Mfg. by Varian Medical Systems, Haan GmbH.
Designed for brachytherapy intra Terminated |
JAQ | K983436 |
| Nov 23, 2011 | Varian Medical Systems, Inc. Varian Medical Systems, Flexible Probe with Blocking Water, GM11002420, (Part of the Segmented Cylinder Set, GM11004150) Terminated |
JAQ | K033371 |
| Aug 22, 2011 | Varian Medical Systems, Inc. Oncology Systems Flexible Probe with Blocking Washer (part of Segmented Cylinder Set)
The Segmented Cylinder Applicator Set was developed to treat cancer of the vagina, vaginal stump and rectum. Terminated |
JAQ | K033371 |
| Aug 12, 2011 | Varian Medical Systems, Inc. Oncology Systems GammaMed Flexible Applicator probe; 3.2mm diameter, braced PVDF.
Varian Medical Systems, Palo Alto, CA.
Mfg by Varian Medical Systems, Haan GmbH.
Flexible Applicator Robes are designed for brachythe Terminated |
JAQ | K983436 |
| Aug 11, 2011 | Varian Medical Systems, Inc. Oncology Systems Titanium Fletcher-style Applicator Set - Defined Geometry - CT Compatible with Titanium intrauterine probe with stopper length 70 mm, 30 degree angle.
Varian Medical Systems, Palo Alto, CA;
Manufactu Terminated |
JAQ | K983436 |
| Aug 11, 2011 | Varian Medical Systems, Inc. Oncology Systems Titanium Fletcher-style Applicator Set - Defined Geometry - CT Compatible with Titanium intrauterine probe with stopper length 50 mm, 30 degree angle.
Varian Medical Systems, Palo Alto, CA;
Manufactu Terminated |
JAQ | K983436 |
| Aug 11, 2011 | Varian Medical Systems, Inc. Oncology Systems Titanium Fletcher-style Applicator Set - Defined Geometry - CT Compatible with Titanium intrauterine probe with stopper length 30 mm, 30 degree angle.
Varian Medical Systems, Palo Alto, CA;
Manufactu Terminated |
JAQ | K983436 |
| Aug 11, 2011 | Varian Medical Systems, Inc. Oncology Systems Titanium Fletcher-style Applicator Set - Defined Geometry - CT Compatible with Titanium intrauterine probe with stopper length 80 mm, 30 degree angle.
Varian Medical Systems, Palo Alto, CA;
Manufactu Terminated |
JAQ | K983436 |
| Aug 11, 2011 | Varian Medical Systems, Inc. Oncology Systems Titanium Fletcher-style Applicator Set - Defined Geometry - CT Compatible with Titanium intrauterine probe with stopper length 60 mm, 30 degree angle.
Varian Medical Systems, Palo Alto, CA;
Manufactu Terminated |
JAQ | K983436 |
| Aug 11, 2011 | Varian Medical Systems, Inc. Oncology Systems Titanium Fletcher-style Applicator Set - Defined Geometry - CT Compatible with Titanium intrauterine probe with stopper length 40 mm, 30 degree angle.
Varian Medical Systems, Palo Alto, CA;
Manufactu Terminated |
JAQ | K983436 |
| Aug 10, 2011 | Varian Medical Systems, Inc. Oncology Systems GammaMed Plastic Needle with Mandrin; 2.0mm diameter, length 320 mm.
Remote controlled radionuclide applicator system.
Varian Medical Systems, Inc.
Mfg by Varian Medical Systems Haan GmbH, Haan, Germ Terminated |
JAQ | K983436 |
| Aug 10, 2011 | Varian Medical Systems, Inc. Oncology Systems GammaMed Plastic Needle with Mandrin; 2.0mm diameter, length 200 mm.
Remote controlled radionuclide applicator system.
Varian Medical Systems, Inc.
Mfg by Varian Medical Systems Haan GmbH, Haan, Germ Terminated |
JAQ | K983436 |
| Aug 10, 2011 | Varian Medical Systems, Inc. Oncology Systems GammaMed Plastic Needle with Mandrin; 2.0mm diameter, length 113 mm.
Remote controlled radionuclide applicator system.
Varian Medical Systems, Inc.
Mfg by Varian Medical Systems Haan GmbH, Haan, Germ Terminated |
JAQ | K983436 |
| Jun 1, 2009 | Siemens Medical Solutions USA, Inc Mammo Test Model number 10144185, x-ray guided stereotactic biopsy system Terminated |
JAQ | K042095 |
| Sep 16, 2008 | Varian Medical Systems, Inc. VariSource CT/MR Ring & Tandem Applicator Set, catalog # AL13017000, containing 32mm titanium ring applicators, each identified as part numbers AL07362000, AL07363000, and AL07364000. Terminated |
JAQ | K030110 |
| Jan 11, 2007 | Varian Medical Systems GammaMed 12it radionuclide applicator system, Varian Medical Systems, Palo Alto, CA. Terminated |
JAQ | None listed |
| Jan 11, 2007 | Varian Medical Systems GammaMed 12i radionuclide applicator systems, distributed by Varian Medical Systems, Palo Alto, CA Terminated |
JAQ | K891131 K912555 |
| Aug 10, 2006 | Varian Medical Systems GammaMed software program, version 5.07, vers. 5.08, vers.-usa, vers.-tst and vers.-row , part number GM11005400, for the GammaMed model 12it radionuclide applicator system. Terminated |
JAQ | K912555 |
| Aug 10, 2006 | Varian Medical Systems GammaMed software program, version 5.07, vers. 5.08, vers.-usa, vers.-tst and vers.-row , part number GM11005400, for the GammaMed model 12i radionuclide applicator system. Terminated |
JAQ | K891131 |
| Jul 27, 2006 | Varian Medical Systems GammaWin software, part number GM11019110, versions up to and including 1.62, for the MammoSource radionuclide applicator system, for radiation therapy. Terminated |
JAQ | K040541 |
| Jul 27, 2006 | Varian Medical Systems GammaWin software, part number GM11019110, versions up to and including 1.62, for the GammaMedplus 3/24 radionuclide applicator system, for radiation therapy. Terminated |
JAQ | K031524 |
| Jul 27, 2006 | Varian Medical Systems GammaWin software, part number GM11019110, versions up to and including 1.62, for the GammaMedplus radionuclide applicator system, for radiation therapy. Terminated |
JAQ | K983436 |
| Apr 27, 2006 | Alpha Omega Services Inc VariSource AL13198000, Intralumenal Kit Terminated |
JAQ | None listed |
| Apr 27, 2006 | Alpha Omega Services Inc KTV0006-002, AOS Tongue And Soft Tissue Kit: AOS Tngue And Soft Tissue Inplant Tubes (20EA); 20CM S.S. Implant Needles, 14 Degrees (20EA) Terminated |
JAQ | None listed |
| Apr 27, 2006 | Alpha Omega Services Inc VariSource AL 13197000, Tongue/Soft Tissue Kit Terminated |
JAQ | None listed |
| Apr 27, 2006 | Alpha Omega Services Inc KCV0008-001, AOS Intralumenal Kit: Intralumenal Implant Tubes (5EA) Terminated |
JAQ | None listed |
| Apr 27, 2006 | Alpha Omega Services Inc VariSource AL 13199024, Implant Tube, Implant Tube, Intralumenal(HDR), 10CM Drawdown 130CM Body, Sealed End, Cable Insert & Gold Seed, Disposable Terminated |
JAQ | None listed |
| Apr 27, 2006 | Alpha Omega Services Inc TIT0001-003, Implant Tube, Tongue/Soft Tissue, Puthawala/Syed:28cm Leader, 85cm Body, 15cm Draw-Down, Cable Insert, & Nylon Retaining Buttons Terminated |
JAQ | None listed |
| Apr 27, 2006 | Alpha Omega Services Inc VariSource AL 13199023 Implant Tube, Tongue/Soft Tissue, Puthawala/Syed:28cm Leader, 85cm Body, 15cm Draw-Down, Cable Insert, & Nylon Retaining Buttons: 20/PKG Terminated |
JAQ | None listed |
| Apr 27, 2006 | Alpha Omega Services Inc TII0002 Implant Tube, Implant Tube, Intralumenal(HDR), 10CM Drawdown 130CM Body, Sealed End, Cable Insert & Gold Seed, Disposable Terminated |
JAQ | None listed |
| Jun 22, 2005 | Varian Medical Systems Flexible Implant tube, blind end, 350 mm, part # GM11003730, labeled in part ***Varian Medical Systems, Inc 3100 Hansen Way Palo Alto, CA 94304 USA www.varian.com***. Available as single unit or con Terminated |
JAQ | K983436 |
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