ClearanceBrief
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)
Get daily alerts for IYESample briefCSV

Top companies in IYE

DateFirm and productCodeLinked 510(k)
Jun 23, 2011Siemens Medical Solutions USA, Inc - Radiation Oncology
ONCOR Impression, camera imaging system, Part Number: 5857920; Product is manufactured and distributed by SIEMENS MEDICAL SOLUTIONS USA, INC. Concord, CA; and SIEMENS AG, MEDICAL SOLUTIONS Roentge
Terminated
IYEK993425
Jun 23, 2011Siemens Medical Solutions USA, Inc - Radiation Oncology
ONCOR Avant Garde , camera imaging system, Part Number:5863472; Product is manufactured and distributed by SIEMENS MEDICAL SOLUTIONS USA, INC. Concord, CA; and SIEMENS AG, MEDICAL SOLUTIONS Roentge
Terminated
IYEK031764
Jun 23, 2011Siemens Medical Solutions USA, Inc - Radiation Oncology
PRIMUS HI, camera imaging system, Part Number: 4504200; Product is manufactured and distributed by SIEMENS MEDICAL SOLUTIONS USA, INC. Concord, CA; and SIEMENS AG, MEDICAL SOLUTIONS Roentgenstrasse,
Terminated
IYEK993425
Jun 23, 2011Siemens Medical Solutions USA, Inc - Radiation Oncology
MEV ATRON M2/PRIMUS MID-ENERGY, camera imaging system, Part Number: 1940035; Product is manufactured and distributed by SIEMENS MEDICAL SOLUTIONS USA, INC. Concord, CA; and SIEMENS AG, MEDICAL SOLUTI
Terminated
IYEK993425
Jun 23, 2011Siemens Medical Solutions USA, Inc - Radiation Oncology
MEV ATRON PRIMART, camera imaging system, Part Number: 5500371; Product is manufactured and distributed by SIEMENS MEDICAL SOLUTIONS USA, INC. Concord, CA; and SIEMENS AG, MEDICAL SOLUTIONS Roentgen
Terminated
IYEK982502
Jun 23, 2011Siemens Medical Solutions USA, Inc - Radiation Oncology
MEVATRONKD-2, camera imaging system, Part Number: 8515520; Product is manufactured and distributed by SIEMENS MEDICAL SOLUTIONS USA, INC. Concord, CA; and SIEMENS AG, MEDICAL SOLUTIONS Roentgenstras
Terminated
IYEK862339
Jun 23, 2011Siemens Medical Solutions USA, Inc - Radiation Oncology
MEVATRONKD, camera imaging system, Part Number: 8319857; Product is manufactured and distributed by SIEMENS MEDICAL SOLUTIONS USA, INC. Concord, CA; and SIEMENS AG, MEDICAL SOLUTIONS Roentgenstrass
Terminated
IYEK862339
Jun 23, 2011Siemens Medical Solutions USA, Inc - Radiation Oncology
Mevatron K2, camera imaging system, Part Number: 1940753; Product is manufactured and distributed by SIEMENS MEDICAL SOLUTIONS USA, INC. Concord, CA; and SIEMENS AG, MEDICAL SOLUTIONS Roentgenstrass
Terminated
IYEK862339
Jun 23, 2011Siemens Medical Solutions USA, Inc - Radiation Oncology
BEAMVIEW IT, camera imaging system, Part Number: 5410389 & 5852301; Product is manufactured and distributed by SIEMENS MEDICAL SOLUTIONS USA, INC. Concord, CA; and SIEMENS AG, MEDICAL SOLUTIONS Roe
Terminated
IYEK903139
Jun 2, 2011Siemens Medical Solutions USA, Inc
ARTISTE or ONCOR Linear Accelerators in combination with 160MLC (Multi Leaf Collimator). Linear Accelerators that may be affected are: ARTISTE MV System; ONCOR Avant Garde ONCOR Impression ONCOR Impre
Terminated
IYEK072486
K092145
May 23, 2011Siemens Medical Solutions USA, Inc
ARTISTE , ONCOR and PRIMUS digital accelerators with syngo RT Therapist v4.1 and 4.2 system; Therapist Express Basic, syngo RT Therapist and syngo RT Therapist Connect/MOSAIQ OIS. The ONCOR and PRIMUS
Terminated
IYEK060226
K072486 +1
May 20, 2011Varian Medical Systems, Inc. Oncology Systems
Varian brand Clinac and TrueBeam, High Energy Linear Accelerator, Model Numbers: H14, H19, H29; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA Indicated for ste
Terminated
IYEK100890
May 19, 2011Siemens Medical Solutions USA, Inc
ARTISTE , ONCOR and PRIMUS accelerators that utilize the RT Therapist v4.2 system in combination with syngo RT Oncologist 4.2. The ONCOR and PRIMUS may be updated to utilize the RT Therapist v4.2 soft
Terminated
IYEK060226
K072486 +1
May 16, 2011Varian Medical Systems, Inc. Oncology Systems
Optical Guidance Platform, Version 2.6 and 2.6.1, Model Number: HZl, Manufactured and Distributed by: Varian Medical Systems Inc., Palo Alto, CA. For use with a charged particle accelerator to perfor
Terminated
IYEK071360
May 13, 2011Varian Medical Systems, Inc. Oncology Systems
Varian brand Clinac, Medical Linear Accelerator, All Varian Clinac with Model Numbers: H14, H18, H26, H27, H28, H29, Hcx; Product is manufactured and distributed by Varian Medical Systems Inc., Palo
Terminated
IYEK100890
May 12, 2011Siemens Medical Solutions USA, Inc
ARTISTE / RT Therapist v4.1 system. The ONCOR and PRIMUS system may be updated to utilize the RT Therapist v4.1 software. Siemens Healthcare, Concord, CA. The intended use is to deliver X-ray photon
Terminated
IYEK060226
K072486 +1
May 10, 2011Varian Medical Systems, Inc. Oncology Systems
Varian Medical System TrueBeam system for stereotactic radiosurgery and radiotherapy. Model number H19;
Terminated
IYEK092871
May 10, 2011Varian Medical Systems, Inc. Oncology Systems
Optical Guidance Platform, version 2.6 and 2.6.1; Reference/FSCA Identifier: CP-03976; Model Number: HZ1; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA Optica
Terminated
IYEK071360
May 2, 2011Varian Medical Systems, Inc. Oncology Systems
ARIA, RT Chart Application v 8.0 through 8.9 Varian Medical Systems, Palo Alto, CA. Aria Radiation Oncology product is a treatment plan and image management application. It enables the authorized use
Terminated
IYEK093527
Apr 29, 2011Varian Medical Systems, Inc. Oncology Systems
The 4D Integrated Treatment Console; Model Number: H51; Reference: 4DITC versions 8.6 and below; File Reference: CP-2007-0288; Product is manufactured and distributed by Varian Medical Systems Inc., P
Terminated
IYEK091132
Apr 25, 2011Varian Medical Systems, Inc. Oncology Systems
Optical Guidance Platform, version 2.6 and 2.6.1; Reference/FSCA Identifier: CP-03899; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA Optical Guidance Platform
Terminated
IYEK071360
Apr 15, 2011Siemens Medical Solutions USA, Inc
Siemens LANTIS 6.1 Oncology Information System with MEDOne Module, Linear Medical Accelerators; Product Numbers: 4503178, 5835991, 5851055; Product is manufactured by IMPAC Medical, Inc., Sunnyvale, C
Terminated
IYEK060226
Apr 13, 2011Siemens Medical Solutions USA, Inc
LANTIS oncology Information System, an accessory to the Linear Accelerator, as part of the COHERENCE RT Therapist, but also cleared under the ONCOR Avante-Garde and Expression, as well as the syngo RT
Terminated
IYEK031764
K060226 +2
Apr 12, 2011Varian Medical Systems, Inc. Oncology Systems
Varian Medical Systems, Varis Vision - RT Chart version 7.3.10. For radiation therapy.
Terminated
IYEK001643
Apr 7, 2011Varian Medical Systems, Inc. Oncology Systems
ARIA versions 8.0 and 8.1 Varian Medical Systems, Palo Alto, CA 94304 The ARIA Radiation Oncology product is a treatment plan and image management application. It enables the authorized user to enter
Terminated
IYEK093527
Mar 22, 2011Elekta, Inc.
Elekta Synergy XVI R4.5 Radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.
Terminated
IYEK051932
Mar 7, 2011Siemens Medical Solutions USA, Inc
MOSAIQ Oncology Information System Intended Use : Electronic Patient Records Management
Terminated
IYENone listed
Mar 4, 2011Elekta, Inc.
Desktop Pro 4.2, 5.0, 5.1, 6.0, 6.2 A user interface of rthe SL/SLi Series Linear Accelerators that are used for radiation therapy treatments of malignant neoplastic diseases, as determined by a lice
Terminated
IYEK982713
Mar 4, 2011Siemens Medical Solutions USA, Inc
Siemens brand ARTISTE System Digital Linear Accelerator with the syngo RT Therapist version 4.1 Connected to MOSAIQ, Part No. 8168754, Distributed by Siemens Medical Solutions Oncology Care System, Co
Terminated
IYEK072485
K090683
Feb 24, 2011Varian Medical Systems, Inc. Oncology Systems
Clinac High Energy Medical Linear Accelerator, a Trilogy Radiotherapy Delivery System; Model #s: H14, H18, H27, H29, HCX; Product is manufactured and distributed by Varian Medical Systems Inc., Palo A
Terminated
IYEK100890
Feb 24, 2011Siemens Medical Solutions USA, Inc., Concord, CA
Siemens brand ARTISTE MV with Artiste Digital Linear Accelerators in combination with the Flat Panel Positioner; Part No. 8139789; Intended use: To deliver x-ray radiation for therapeutic treatment
Terminated
IYEK072485
Feb 15, 2011Elekta, Inc.
Elekta Synergy XVI Intended use: Radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.
Terminated
IYEK051932
Feb 15, 2011Varian Medical Systems Oncology Systems
Varian Radiotherapy delivery system (C-Series Clinac, Trilogy and Novalis Tx), model numbers H14, H17, H18, H23, H26, H29, HCX
Terminated
IYEK070094
K904364 +1
Feb 8, 2011Varian Medical Systems, Inc. Oncology Systems
Varian High Energy Linear Accelerator: Varian Medical Systems, Palo Alto, CA 94304 Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in t
Terminated
IYEK100890
Feb 8, 2011Siemens Medical Solutions USA, Inc
Linear Medical Accelerator ARTISTE MV systems, when equipped with a syngo RT Therapist, Therapist Express Basic, syngo RT Therapist Assist or Therapist Express Assist workspace with software version N
Terminated
IYEK072485
Feb 4, 2011Impac Medical Systems Inc
SEQUENCER for Mosaiq interfaced to Electa SL75-5 machines. Sequencer Verify and Record System is to assist in the process of patient treatment on a radiotherapy treatment machine with software contro
Terminated
IYEK981313
Feb 1, 2011Varian Medical Systems Oncology Systems
Varian brand C-Series Clinacs and Acuity, Exact Couch Top, Model Numbers: H69, Product is manufactured and distributed by: Varian Medical Systems Inc., Palo Alto, CA
Terminated
IYEK033339
K904364
Jan 31, 2011Varian Medical Systems Oncology Systems
Varian brand C Series Clinics (Includes Trilogy, and Novalis Tx), Model Numbers: H14, H26, H27, H29, Distributed by and/or Manufactured by: Varian Medical Systems Inc., Palo Alto, CA The system cons
Terminated
IYEK072916
K092871
Jan 21, 2011Varian Medical Systems, Inc. Oncology Systems
4D Integrated Treatment Console (4DITC); All versions up to and including 8.8.17 Varian Medial Systems, Palo Alto, CA Designed to assist the operator of a radiation device in providing accurate treat
Terminated
IYEK081036
Jan 18, 2011Siemens Medical Solutions, Oncology Care Systems, 4040 Nelson Ave., Concord, CA 94510
ARTISTE and ONCOR Digital Linear Accelerators configured with the 160 leaf Multi-Leaf Collimator (MLC) and MEVATRON and PRIMUS Digital Linear Accelerators configured with the High Performance Defining
Terminated
IYENone listed
Jan 18, 2011Varian Medical Systems Oncology Systems
C-Series Clinac, Trilogy and Novalis Tx used for SRS treatments, Model Numbers H14, H18, H27, H29, HCX, manufactured by Varian Medical Systems, Palo Alto, CA. Device is a radiation Therapy accelerat
Terminated
IYEK070094
K913119
Jan 18, 2011Accuray Inc
CyberKnife System Robotic Radiosurgery System, (Robocouch Patient positioning System) Synchrony Respiratory Tracking System, a Radiation therapy device, Model Numbers: 026430, 028186, Product is manuf
Terminated
IYEK020294
K072504
Jan 18, 2011Accuray Inc
CyberKnife System Robotic Radiosurgery System, (Standard Treatment Couch) Synchrony Respiratory Tracking System, a Radiation Therapy Device, Model Numbers: 026429, 028185, Product is manufactured and
Terminated
IYEK020294
K072504
Jan 10, 2011Varian Medical Systems Oncology Systems
4D Integrated Treatment Console, versions: 8.0.12, 8.0.23 SP2, 8.1 SP2, 8.1.1.3, 8.1.1.4, 8.1.2, 8.1.3, 8.1.4, 8.3, 8.6, 8.6.1, 8.6.2, 8.8.0; Model Number: H51; Distributed and manufactured by: Varian
Terminated
IYEK091132
Jan 10, 2011Varian Medical Systems Oncology Systems
Varian Medical Systems Floorstand. An accessory of the Optical Guidance Platform, Model number HZ5 for use with a charged particle accelerator (such as the Clinac 600C).
Terminated
IYEK071360
Dec 29, 2010Varian Medical Systems Oncology Systems
Varian Medical Systems FastPlan software, Versions 5.5 and 5.5.1, Model Number HZ3, manufactured by Varian Medical Systems, Palo Alto, CA Treatment Planning System is intended as aid in quickly and pr
Terminated
IYEK962792
Dec 28, 2010Varian Medical Systems Inc.
Varian brand Trilogy System with RapidArc, Model Numbers: H14, H26, H27, H29; Distributed and Manufactured by: Varian Medical Systems Inc., Palo Alto, CA
Terminated
IYEK072916
Dec 16, 2010Accuray Inc
CyberKnife Robotic Radiosurgery System, medical charged-particle radiation therapy system, manufactured by Accuray Inc., Sunnyvale, CA. Indicated for treatment planning and image-guided stereotactic
Terminated
IYEK091999
Dec 3, 2010Elekta, Inc.
Elekta VBH Head FIX The VBH HeadFIX is intended for positioning and immobilization of the head and neck, stereotactic diagnostic localization and stereotactic radiotherapy of cranial targets.
Terminated
IYEK030439
Nov 24, 2010Siemens Medical Solutions USA, Inc
Siemens brand ARTISTE MV, Artiste Digital Linear Accelerators in combination with the Flat Panel, Part No. 8139789, To deliver x-ray radiation for therapeutic treatment of cancer. Product is manufact
Terminated
IYEK072485

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.