510(k) K983436 ยท JAQ System, Applicator, Radionuclide, Remote-Controlled
GAMMAMED PLUS HIGH DOSE RATE REMOTE AFTERLOADING SYSTEM
| Applicant | Gammamed USA, Ann Arbor MI, US |
| Decision | Substantially Equivalent, Oct 29, 1998 |
| Received | Sep 29, 1998 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K983436
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.