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Panels › Radiology › Product code IYE · Class 2

Accelerator, Linear, Medical

Regulation 892.5050

15510(k)s in 12 months (738 all time)
8recalls in 12 months (563 all time)
542recalls that name a 510(k)
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Top companies in IYE

DateFirm and productCodeLinked 510(k)
Jan 17, 2012Siemens Medical Solutions USA, Inc
Mevatron KD2; Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVATRON Linear Accelerators are intended to deliver X-ray photon and electron radiation for the therapeutic treatment
Terminated
IYEK882729
Jan 17, 2012Siemens Medical Solutions USA, Inc
Mevatron ME; Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVATRON Linear Accelerators are intended to deliver X-ray photon and electron radiation for the therapeutic treatment o
Terminated
IYEK882729
Jan 17, 2012Siemens Medical Solutions USA, Inc
Mevatron KD; Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVATRON Linear Accelerators are intended to deliver X-ray photon and electron radiation for the therapeutic treatment o
Terminated
IYEK882729
Jan 17, 2012Siemens Medical Solutions USA, Inc
Mevatron MD (MD, MDX); Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVATRON Linear Accelerators are intended to deliver X-ray photon and electron radiation for the therapeutic t
Terminated
IYEK882729
Jan 17, 2012Siemens Medical Solutions USA, Inc
Mevatron M 6730/6740; Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVATRON Linear Accelerators are intended to deliver X-ray photon and electron radiation for the therapeutic tr
Terminated
IYEK882729
Jan 17, 2012Siemens Medical Solutions USA, Inc
Mevatron M 6300 (MX); Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVATRON Linear Accelerators are intended to deliver X-ray photon and electron radiation for the therapeutic tr
Terminated
IYEK882729
Jan 17, 2012Siemens Medical Solutions USA, Inc
Mevatron M 6700 (MX); Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVATRON Linear Accelerators are intended to deliver X-ray photon and electron radiation for the therapeutic tr
Terminated
IYEK882729
Jan 17, 2012Siemens Medical Solutions USA, Inc
Mevatron 67; Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVATRON Linear Accelerators are intended to deliver X-ray photon and electron radiation for the therapeutic treatment o
Terminated
IYEK882729
Jan 17, 2012Siemens Medical Solutions USA, Inc
Mevatron M 7400/7440 (MXE); Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVATRON Linear Accelerators are intended to deliver X-ray photon and electron radiation for the therapeu
Terminated
IYEK882729
Jan 17, 2012Siemens Medical Solutions USA, Inc
Mevatron 77; Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVATRON Linear Accelerators are intended to deliver X-ray photon and electron radiation for the therapeutic treatment o
Terminated
IYEK882729
Jan 17, 2012Siemens Medical Solutions USA, Inc
PRIMUS HI; Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVATRON Linear Accelerators are intended to deliver X-ray photon and electron radiation for the therapeutic treatment of
Terminated
IYEK993425
Jan 17, 2012Siemens Medical Solutions USA, Inc
Mevatron K2; Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVATRON Linear Accelerators are intended to deliver X-ray photon and electron radiation for the therapeutic treatment o
Terminated
IYEK882729
Jan 17, 2012Siemens Medical Solutions USA, Inc
Mevatron M2/PRIMUS Mid; Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVATRON Linear Accelerators are intended to deliver X-ray photon and electron radiation for the therapeutic
Terminated
IYEK882729
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, 2012Philips Medical Systems (Cleveland), Inc.
Pinnacle3 Radiation Therapy Planning System, software version 9.0. Model # Description 453560446041 Pinnacle3 version 9.0 English 453560446051 Pinnacle3 version 9.0 Simplified Chinese 453
Terminated
IYEK041577
Jan 11, 2012Siemens Medical Solutions USA, Inc
ARTISTE and ONCOR linear accelerators with G31 mother board. ARTISTE and ONCOR are manufactured by Siemens Medical Solutions, Roentgenstrasse 19-21, Kemnath, Germany. ARTISTE, ONCOR and PRIMUS famil
Terminated
IYEK060226
K103505
Jan 11, 2012Siemens Medical Solutions USA, Inc
syngo RT Therapist and syngo RT Therapist Connect/MOSAIQ OIS. This correction applies to customers who use the syngo RT Therapist v4.2 or the combination of syngo RT Therapist v4.2 with syngo RT Oncol
Terminated
IYEK103606
Jan 11, 2012Accuray Incorporated
CyberKnife Robotic Radiosurgery System: Lung Optimized Treatment option. The CyberKnife treatment is indicated for the treatment planning and image guided stereotactic radiosurgery and precision radi
Terminated
IYEK091999
Dec 1, 2011Elekta, Inc.
Elekta Synergy XVI X-ray Volume Imaging System To be used as part of radiation therapy treatment process.
Terminated
IYEK100115
Dec 1, 2011Elekta, Inc.
Elekta Synergy XVI R.4.5 and R4.6 ProducT Usage: To be used as part of radiation therapy treatment process.
Terminated
IYEK100115
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
Nov 29, 2011Elekta, Inc.
Elekta Synergy XVI 4.5 Product Usage: Radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.
Terminated
IYEK051932
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
Oct 17, 2011Impac Medical Systems Inc
Impac Medical Systems Sequencer Product Usage: The intended us of Sequencer is to assists in the process of patient treatment on a radiotherapy treatment machine. Sequencer provides the capability t
Terminated
IYEK981313
Oct 11, 2011Accuray Incorporated
CyberKnife Robotic Radiosurgery System, Synchrony Respiratory Tracking System (Robocouch Patient Positioning System), a Radiation Therapy Device. Model Numbers: 026430, 028186. Product is manufacture
Terminated
IYEK102650
Oct 11, 2011Accuray Incorporated
CyberKnife Robotic Radiosurgery System, Synchrony Respiratory Tracking System (Standard Treatment Couch). Synchrony Respiratory Tracking System, a Radiation Therapy Device, Model Numbers: 026429, 0281
Terminated
IYEK102650
Sep 14, 2011Varian Medical Systems, Inc.
Varian Medical Systems Inc., Millennium and HD-120 MultiLeaf Collimators (MLC), a component of the Clinac, All Varian Clinac using the collimator cover P/N 1106900-xx, Model Numbers: H14, H18, H27, H
Terminated
IYEK100890
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
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 11, 2011Siemens Medical Solutions USA, Inc
ARTISTE Linear Accelerator with RT Therapist v4.1 system. Siemens Medical Solutions, Kemnath, Germany. Distributed by Siemens Medical Solutions, Concord, CA 94520. Product Usage: Linear Accelerators
Terminated
IYEK060226
K072485 +1
Aug 10, 2011Siemens Medical Solutions USA, Inc
ARTISTE/RT Therapist v4.2 and/or Oncologist v4.2 systems. Manufactured by Siemens AG, Medical Solutions, Kemnath, Germany. Delivery of X-ray photon and electron radiation for the therapeutic treatmen
Terminated
IYEK080906
Aug 10, 2011Varian Medical Systems, Inc. Oncology Systems
Clinac, Trilogy. Trilogy Tx and Novalis Tx Linear Accelerators. Varian Medical Systems, Inc. Oncology Systems Intended for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and
Terminated
IYEK033343
K100890
Jul 28, 2011Varian Medical Systems, Inc. Oncology Systems
Clinac Linear Accelerators; Varian Medical Systems, Palo Alto, CA. Radiation Therapy intended to deliver megavoltage x-ray treatments for conventional radiotherapy and stereotactic radiosurgery and r
Terminated
IYEK100890
Jul 11, 2011Siemens Medical Solutions USA, Inc
ONCOR/PRIMUS Linear Accelerator systems with RTT v2.x AND an ARTISTE Linear Accelerator/RT Therapist v4.1 system with the LANTIS OIS. The Linear Accelerators are used to deliver X-ray photon and elec
Terminated
IYEK060226
K072486 +1
Jul 11, 2011Varian Medical Systems, Inc. Oncology Systems
Clinac iX, 23EX, CX, DHXC, Novalis Tx, Trilogy and TrueBeam Linear Accelerators Drive Stands Indicated for sterostatic radiosurgery and precision radiotherapy for lesions, tumors and conditions anyw
Terminated
IYEK033343
K100890
Jul 8, 2011Varian Medical Systems, Inc. Oncology Systems
TrueBeam Linear Accelerators (aka Trilogy Mx) Varian Medical Systems, Palo Alto, CA Product Usage: Intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors , and c
Terminated
IYEK092871
Jul 8, 2011Varian Medical Systems, Inc. Oncology Systems
Clinac Linear Accelerator; Model numbers H14, H27 and H29. Product Usage: Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tu
Terminated
IYEK100890
Jul 8, 2011Varian Medical Systems, Inc. Oncology Systems
ARIA, versions 8.0 and 8.1; Varian Medical Systems, Palo Alto, CA. Product Usage: Aria Radiation Oncology product is a treatment and image management application. It enables the authorized user to e
Terminated
IYEK093527
Jun 24, 2011Impac Medical Systems Inc
Elekta Impac Software Sequencer Verify & Record System, for MOSAIQ The intended use of Sequencer (generically referred to as a verification system) is to assist in the process of process of patient t
Terminated
IYEK981313
Jun 23, 2011Siemens Medical Solutions USA, Inc - Radiation Oncology
ONCOR Impression Plus, camera imaging system, Part Number: 5857912, Product is manufactured and distributed by SIEMENS MEDICAL SOLUTIONS USA, INC. Concord, CA; and SIEMENS AG, MEDICAL SOLUTIONS Roen
Terminated
IYEK993425

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