ClearanceBrief
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

CodeDeviceRecords
IYEAccelerator, Linear, Medical70
MUJSystem, Planning, Radiation Therapy Treatment18
JAQSystem, Applicator, Radionuclide, Remote-Controlled13
-IY1
GKZCounter, Differential Cell1
KPQSystem, Simulation, Radiation Therapy1
LHNSystem, Radiation Therapy, Charged-Particle, Medical1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Dec 7, 2012K123152VITESSE 3.0
Varian Medical Systems, Oncology Systems
MUJ
Jan 12, 2011K103394BARCODE CONICAL COLLIMATOR VERIFICATION (BCCV)
Varian Medical Systems, Oncology Systems
IYE
Dec 27, 2010K101294PT2 VARIAN PROTON THERAPY SYSTEM
Varian Medical Systems, Oncology Systems
LHN
Aug 10, 2010K101751VARIAN UNIQUE SINGLE ENERGY LINEAR ACCELERATOR
Varian Medical Systems, Oncology Systems
IYE

Latest recalls

DateFirm and productCodeLinked 510(k)
May 15, 2013Varian 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
IYEK100890
Apr 23, 2013Varian 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
IYEK102024
Feb 20, 2013Varian 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
MUJK102011
Dec 17, 2012Varian 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
IYEK093527
Nov 1, 2012Varian 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
IYEK093527
Sep 26, 2012Varian 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
MUJK102011
Sep 14, 2012Varian 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
IYEK081188
K926321
Aug 8, 2012Varian 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
IYEK093527
Jul 19, 2012Varian 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
MUJNone listed
May 16, 2012Varian 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
IYEK111106
May 8, 2012Varian 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
IYEK111106
Mar 16, 2012Varian 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
IYEK962792
Mar 6, 2012Varian 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
MUJK102011
Mar 6, 2012Varian 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
IYEK111106
Feb 23, 2012Varian 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
IYEK050442
K071992 +1
Feb 23, 2012Varian 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
IYEK050442
K071992 +1
Feb 3, 2012Varian 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
IYEK990085
Jan 13, 2012Varian 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
MUJK102011
Jan 11, 2012Varian 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
IYEK093527
Jan 11, 2012Varian 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
IYEK091132
K111106
Jan 11, 2012Varian 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
IYEK103394
Jan 11, 2012Varian 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
IYEK091132
Jan 11, 2012Varian 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
IYEK112839
K926321
Jan 11, 2012Varian 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
IYEK091209
Jan 11, 2012Varian 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
IYEK101751
Jan 11, 2012Varian 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
MUJK091492
Dec 2, 2011Varian 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
-IYK111106
Dec 1, 2011Varian 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
IYEK071360
Dec 1, 2011Varian 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
JAQK891131
Dec 1, 2011Varian 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
JAQK891131
Nov 9, 2011Varian 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
IYEK033343
K100890
Sep 14, 2011Varian 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
IYEK091132
Aug 31, 2011Varian 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
IYEK093967
Aug 31, 2011Varian 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
IYEK081036
Aug 31, 2011Varian 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
IYEK042720
K092871
Aug 30, 2011Varian 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
IYEK081036
Aug 22, 2011Varian 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
JAQK033371
Aug 22, 2011Varian 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
IYEK071992
Aug 15, 2011Varian 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
MUJK073020
Aug 12, 2011Varian 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
JAQK983436
Aug 11, 2011Varian 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
JAQK983436
Aug 11, 2011Varian 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
JAQK983436
Aug 11, 2011Varian 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
JAQK983436
Aug 11, 2011Varian 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
JAQK983436
Aug 11, 2011Varian 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
JAQK983436
Aug 11, 2011Varian 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
JAQK983436
Aug 11, 2011Varian 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
MUJK073020
Aug 10, 2011Varian 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
JAQK983436
Aug 10, 2011Varian 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
JAQK983436
Aug 10, 2011Varian 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
JAQK983436

Newest 50 of 102.

Get alerts for these product codes