Company ยท US
Varian Medical Systems, Inc. Oncology Systems
FDA 510(k) clearances and medical device recalls filed under this name, 2010 to 2012. Name variants (Inc, Corp, punctuation) are merged.
4510(k) clearances (0 in 12 months)
102recalls (0 in 12 months)
100recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 7, 2012 | K123152 | VITESSE 3.0 Varian Medical Systems, Oncology Systems | MUJ |
| Jan 12, 2011 | K103394 | BARCODE CONICAL COLLIMATOR VERIFICATION (BCCV) Varian Medical Systems, Oncology Systems | IYE |
| Dec 27, 2010 | K101294 | PT2 VARIAN PROTON THERAPY SYSTEM Varian Medical Systems, Oncology Systems | LHN |
| Aug 10, 2010 | K101751 | VARIAN UNIQUE SINGLE ENERGY LINEAR ACCELERATOR Varian Medical Systems, Oncology Systems | IYE |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 15, 2013 | Varian Medical Systems, Inc. Oncology Systems Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX.
Product Usage:
The Varian High Energy Accelerator is intended to provide stereota Terminated |
IYE | K100890 |
| Apr 23, 2013 | Varian Medical Systems, Inc. Oncology Systems Varian brand RPM Respiratory Gating System, RPM Gating v1.7.5 with 3D Option, Model Number: HS2
Product Usage: The RPM device is to be used to characterize the patients respiratory motion informatio Terminated |
IYE | K102024 |
| Feb 20, 2013 | Varian Medical Systems, Inc. Oncology Systems Varian Eclipse Treatment Planning System for Radiotherapy; Model Number: H48. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the Terminated |
MUJ | K102011 |
| Dec 17, 2012 | Varian Medical Systems, Inc. Oncology Systems Varian brand ARIA Radiation Oncology, ARIA Oncology Information System Radiation Oncology, Import Export Application, Model Number: HIT, Affected Versions: ARIA version 11.0 below 11.0.55, Build 11.0. Terminated |
IYE | K093527 |
| Nov 1, 2012 | Varian Medical Systems, Inc. Oncology Systems ARIA Radiation Oncology, Version 11. Varian Medical Systems, Palo Alto, CA. The ARIA Radiation Oncology product is a treatment plan and image management application. Terminated |
IYE | K093527 |
| Sep 26, 2012 | Varian Medical Systems, Inc. Oncology Systems Varian brand Eclipse Treatment Planning System, Model Number: H48; Eclipse 8.9 and 10.0
Reference/FSCA Identifier: CP-08922; Product is manufactured and distributed by Varian Medical Systems Inc., Pal Terminated |
MUJ | K102011 |
| Sep 14, 2012 | Varian Medical Systems, Inc. Oncology Systems Varian brand Clinac, Trilogy, Novalis Tx, Unique, linear accelerators; Model Number: H14, H18, H29, Reference/FSCA Identifier: CP-08881; Product is manufactured and distributed by Varian Medical Syst Terminated |
IYE | K081188 K926321 |
| Aug 8, 2012 | Varian Medical Systems, Inc. Oncology Systems Varian brand Varian ARIA Oncology Information System, Import Export
application, v 11.0; Reference/FSCA Identifier: CP-08847; Model Number: HIT; Product is manufactured and distributed by Varian Medic Terminated |
IYE | K093527 |
| Jul 19, 2012 | Varian Medical Systems, Inc. Oncology Systems Varian brand Varian Eclipse Treatment Planning System for radiotherapy; Model Number: H48; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA
The Eclipse Treatmen Terminated |
MUJ | None listed |
| May 16, 2012 | Varian Medical Systems, Inc. Oncology Systems TrueBeam and TrueBeam STx V1.0, 1.5, 1.6.95 and below. TrueBeam Radiotherapy Delivery System is intended to provide stereotactic radiosurgery and precision radiotherapy anywhere in the body where radi Terminated |
IYE | K111106 |
| May 8, 2012 | Varian Medical Systems, Inc. Oncology Systems True Beam;
Versions 1.0, 1.5.12.0 and below, 1.6.9.5 and below.
Varian Medical Systems,
Palo Alto, CA.
Product Usage:
TrueBeam Radiotherapy delivery system is intended to provide sterotactic radiosu Terminated |
IYE | K111106 |
| Mar 16, 2012 | Varian Medical Systems, Inc. Oncology Systems FastPlan Treatment Planning System, Model HZ3, Varian Medical Systems, Palo Alto, CA. Varian FastPlan Treatment Planning System is a radiation treatment planning system composed of a high resolution U Terminated |
IYE | K962792 |
| Mar 6, 2012 | Varian Medical Systems, Inc. Oncology Systems Eclipse Treatment Planning System, versions 7.3, 8.0, 8.1, 8.2, 8.6, 8.9 and 10.0;
Model H48
Varian Medical Systems, Palo Alto, CA.
Product Usage:
The Eclipse Treatment Planning System (Eclipse TPS) Terminated |
MUJ | K102011 |
| Mar 6, 2012 | Varian Medical Systems, Inc. Oncology Systems TrueBeam and True Beam STx versions 1.0 through 1.5, Model number H19; Varian Medical Systems, Palo, Alto, CA 94304. TrueBeam Radiotherapy Delivery System is intended to provide stereotactic radiosurg Terminated |
IYE | K111106 |
| Feb 23, 2012 | Varian Medical Systems, Inc. Oncology Systems Varian brand 52-leaf Millennium MLC multileaf collimator;
Reference/FSCA Identifier: CP-04792; All models, including H52, H54, H56, HHM; Product is manufactured and distributed by Varian Medical Syste Terminated |
IYE | K050442 K071992 +1 |
| Feb 23, 2012 | Varian Medical Systems, Inc. Oncology Systems Varian brand Varian 52-leaf Standard MLC multileaf collimator;
Reference/FSCA Identifier: CP-04792; Model Number(s): All models, including
H52, H54, H56, HHM; Product is manufactured and distributed Terminated |
IYE | K050442 K071992 +1 |
| Feb 3, 2012 | Varian Medical Systems, Inc. Oncology Systems Varian brand Varian Clinac Accelerators with Mark, Millennium MLC 120 (Multileaf Collimator) and BrainLAB m3 MCL, Reference/FSCA CP-05591, Model Number: H53, Product is manufactured and distributed by Terminated |
IYE | K990085 |
| Jan 13, 2012 | Varian Medical Systems, Inc. Oncology Systems Varian brand Eclipse Treatment Planning System, 7.3, 8.0, 8.1, 8.2, 8.6, 8.9, 10.0; Model Number: H48;
Reference/FSCA Identifier: CP-07007, Product is manufactured and distributed by Varian Medical S Terminated |
MUJ | K102011 |
| Jan 11, 2012 | Varian Medical Systems, Inc. Oncology Systems Varian brand ARIA Radiation Oncology, ARIA versions 10.0.39 and below, Reference/FSCA Identifier: CP-06070, Model Number: HIT, Product is manufactured and distributed by Varian Medical Systems Inc., P Terminated |
IYE | K093527 |
| Jan 11, 2012 | Varian Medical Systems, Inc. Oncology Systems 4D Integrated Treatment Console (4DITC) TrueBeam Linear Accelerator
Varian Medical Systems, Palo Alto, CA.
The 4DITC is designed to interface to the Varian Clinac Treatment Control System for the pur Terminated |
IYE | K091132 K111106 |
| Jan 11, 2012 | Varian Medical Systems, Inc. Oncology Systems Varian brand Barcode Conical Collimator Verification (BCCV) v1.0, Reference/FSCA Identifier: CP-06873, Model Number: HB, distributed by and/or manufactured by:
Varian Medical Systems Inc., Palo Alto, Terminated |
IYE | K103394 |
| Jan 11, 2012 | Varian Medical Systems, Inc. Oncology Systems Varian brand 4D Integrated Treatment Console (4DITC) v10.2.3, Reference/FSCA Identifier: CP-06873,
Model Number: H51, distributed by and manufactured by:
Varian Medical Systems Inc., Palo Alto, CA
Th Terminated |
IYE | K091132 |
| Jan 11, 2012 | Varian Medical Systems, Inc. Oncology Systems Varian High Energy Linear Accelerator, C-Series Clinac, Reference/FSCA Identifier: CP-06611; Models Numbers: 600C, 600CD, 6EX, DBX, 2100C, 2100CD, 2300CD, 21EX, 23EX, DMX, DHX versions 2.x through 6.x Terminated |
IYE | K112839 K926321 |
| Jan 11, 2012 | Varian Medical Systems, Inc. Oncology Systems Portal Vision, R-Arm with 4D Integrated Treatment Console;
Varian Medical Systems. Palo Alto, CA.
The Portal Vision device is used for verification of the treatment field and shielding block in relat Terminated |
IYE | K091209 |
| Jan 11, 2012 | Varian Medical Systems, Inc. Oncology Systems Varian Unique Single Energy Linear Accelerator, C-Series Clinac or Trilogy, versions 7.x and 8.x, Reference/FSCA Identifier: CP-0661; Model Numbers: H14, H18, H27, H29; Product is manufactured and dis Terminated |
IYE | K101751 |
| Jan 11, 2012 | Varian Medical Systems, Inc. Oncology Systems Varian brand Eclipse Release 10 with RT Chart Release 10 (Client Build 10.0.28 or Build 10.0.34), An
Eclipse Treatment Planning System used with ARIA Radiation Oncology (RT Chart
module), Reference/F Terminated |
MUJ | K091492 |
| Dec 2, 2011 | Varian Medical Systems, Inc. Oncology Systems TrueBeam and TrueBeam STx, Model Number: H19, Ref/FSCA identifier: CP-06381 are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in Terminated |
-IY | K111106 |
| Dec 1, 2011 | Varian Medical Systems, Inc. Oncology Systems Head Ring Posts with part number 970.280 - re-usable components of the Frame Array Module (of the Optical Guidance Platform and Floorstand devices.
Varian Medical Systems, Palo Alto, CA 94304.
The Op Terminated |
IYE | K071360 |
| 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 |
| Nov 9, 2011 | Varian Medical Systems, Inc. Oncology Systems Varian Clinac, Trilogy, Trilogy Tx and Novalis linear accelerators.
Manufactured by Varian Medical System, Palo Alto, CA.
Varian High Energy Linear Accelerator is indicated for stereotactic radiosur Terminated |
IYE | K033343 K100890 |
| Sep 14, 2011 | Varian Medical Systems, Inc. Oncology Systems 4D Integrated Treatment Console v 8.6 with ARIA RT Chart v8.5, all of 4DITC v 8.3;
Varian Medical Systems, Palo Alto, CA
Designed to assist the operator of a radiation therapy device in providing the Terminated |
IYE | K091132 |
| Aug 31, 2011 | Varian Medical Systems, Inc. Oncology Systems Varian Treatment version 6.6.5052.
Varian Medical Systems,
Palo Alto, Ca
Intended to provide accurate treatment set-ups for each patient by monitoring linear accelerator set-up parameters and by pre Terminated |
IYE | K093967 |
| Aug 31, 2011 | Varian Medical Systems, Inc. Oncology Systems Varian brand 4D Integrated Treatment Console (4DITC) Radiation Therapy, version 8.1 SP2 to 10.0 SP1; Model Number: H51; Reference/PSCA Identifier: CP-03940; Product is manufactured and distributed by Terminated |
IYE | K081036 |
| Aug 31, 2011 | Varian Medical Systems, Inc. Oncology Systems On-Board Imager (OBI) 1.3, 1.4, 1.5; and Trilogy Mx, TrueBeam 1.0, Offline Review 1.0 - 2.0;
Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA
The On-Board Imager Terminated |
IYE | K042720 K092871 |
| Aug 30, 2011 | Varian Medical Systems, Inc. Oncology Systems Varian brand 4D Integrated Treatment Console (4DITC) Radiation Therapy, Interpretation of a RapidArc Treatment Plan as a 3D Conformal Arc Treatment Plan; version v8.6 or 8.8 in combination with treat Terminated |
IYE | K081036 |
| 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 22, 2011 | Varian Medical Systems, Inc. Oncology Systems High-Definition 120 Multileaf Collimator
HD 120 MLC is an accessory x-ray collimator designed to be mounted on Varian Trilogy Tx and Trilogy linear accelerators and is intended to shape s-ray field p Terminated |
IYE | K071992 |
| Aug 15, 2011 | Varian Medical Systems, Inc. Oncology Systems Eclipse Treatment Planning System, 4D Structure Merge Tool Option in Eclipse Release 8.5 -10 (Client Build 8.2.2x through 10.0.34) with 4D Planning; Model Number: H48;
Reference/FSCA Identifier: CP- Terminated |
MUJ | K073020 |
| 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 11, 2011 | Varian Medical Systems, Inc. Oncology Systems Eclipse Treatment Planning System;
Varian Medical Systems, Palo Alto, CA
Product Usage: Eclipse Treatment Planning System is used to plan radiotherapy treatments for patients with malignant or beni Terminated |
MUJ | K073020 |
| 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 |
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