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)
Top companies in IYE
| Company | 510(k)s | Recalls |
|---|---|---|
| Siemens Medical Solutions USA, Inc. | 18 | 206 |
| Varian Medical Systems | 83 | 27 |
| Elekta , Ltd. | 19 | 77 |
| Varian Medical Systems, Oncology Systems | 2 | 68 |
| Accuray Incorporated | 19 | 32 |
| Landauer | 1 | 39 |
| Brainlab | 22 | 17 |
| Varian Assoc., Inc. | 27 | 0 |
| Medtec, Inc. | 20 | 0 |
| Sun Nuclear Corp. | 19 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 23, 2011 | Siemens 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 |
IYE | K993425 |
| Jun 23, 2011 | Siemens 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 |
IYE | K031764 |
| Jun 23, 2011 | Siemens 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 |
IYE | K993425 |
| Jun 23, 2011 | Siemens 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 |
IYE | K993425 |
| Jun 23, 2011 | Siemens 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 |
IYE | K982502 |
| Jun 23, 2011 | Siemens 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 |
IYE | K862339 |
| Jun 23, 2011 | Siemens 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 |
IYE | K862339 |
| Jun 23, 2011 | Siemens 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 |
IYE | K862339 |
| Jun 23, 2011 | Siemens 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 |
IYE | K903139 |
| Jun 2, 2011 | Siemens 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 |
IYE | K072486 K092145 |
| May 23, 2011 | Siemens 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 |
IYE | K060226 K072486 +1 |
| May 20, 2011 | Varian 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 |
IYE | K100890 |
| May 19, 2011 | Siemens 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 |
IYE | K060226 K072486 +1 |
| May 16, 2011 | Varian 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 |
IYE | K071360 |
| May 13, 2011 | Varian 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 |
IYE | K100890 |
| May 12, 2011 | Siemens 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 |
IYE | K060226 K072486 +1 |
| May 10, 2011 | Varian Medical Systems, Inc. Oncology Systems Varian Medical System TrueBeam system for stereotactic radiosurgery and radiotherapy. Model number H19; Terminated |
IYE | K092871 |
| May 10, 2011 | Varian 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 |
IYE | K071360 |
| May 2, 2011 | Varian 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 |
IYE | K093527 |
| Apr 29, 2011 | Varian 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 |
IYE | K091132 |
| Apr 25, 2011 | Varian 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 |
IYE | K071360 |
| Apr 15, 2011 | Siemens 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 |
IYE | K060226 |
| Apr 13, 2011 | Siemens 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 |
IYE | K031764 K060226 +2 |
| Apr 12, 2011 | Varian Medical Systems, Inc. Oncology Systems Varian Medical Systems, Varis Vision - RT Chart version 7.3.10. For radiation therapy. Terminated |
IYE | K001643 |
| Apr 7, 2011 | Varian 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 |
IYE | K093527 |
| Mar 22, 2011 | Elekta, Inc. Elekta Synergy XVI R4.5
Radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner. Terminated |
IYE | K051932 |
| Mar 7, 2011 | Siemens Medical Solutions USA, Inc MOSAIQ Oncology Information System
Intended Use : Electronic Patient Records Management Terminated |
IYE | None listed |
| Mar 4, 2011 | Elekta, 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 |
IYE | K982713 |
| Mar 4, 2011 | Siemens 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 |
IYE | K072485 K090683 |
| Feb 24, 2011 | Varian 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 |
IYE | K100890 |
| Feb 24, 2011 | Siemens 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 |
IYE | K072485 |
| Feb 15, 2011 | Elekta, Inc. Elekta Synergy XVI
Intended use: Radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner. Terminated |
IYE | K051932 |
| Feb 15, 2011 | Varian 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 |
IYE | K070094 K904364 +1 |
| Feb 8, 2011 | Varian 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 |
IYE | K100890 |
| Feb 8, 2011 | Siemens 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 |
IYE | K072485 |
| Feb 4, 2011 | Impac 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 |
IYE | K981313 |
| Feb 1, 2011 | Varian 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 |
IYE | K033339 K904364 |
| Jan 31, 2011 | Varian 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 |
IYE | K072916 K092871 |
| Jan 21, 2011 | Varian 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 |
IYE | K081036 |
| Jan 18, 2011 | Siemens 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 |
IYE | None listed |
| Jan 18, 2011 | Varian 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 |
IYE | K070094 K913119 |
| Jan 18, 2011 | Accuray 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 |
IYE | K020294 K072504 |
| Jan 18, 2011 | Accuray 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 |
IYE | K020294 K072504 |
| Jan 10, 2011 | Varian 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 |
IYE | K091132 |
| Jan 10, 2011 | Varian 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 |
IYE | K071360 |
| Dec 29, 2010 | Varian 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 |
IYE | K962792 |
| Dec 28, 2010 | Varian 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 |
IYE | K072916 |
| Dec 16, 2010 | Accuray 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 |
IYE | K091999 |
| Dec 3, 2010 | Elekta, 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 |
IYE | K030439 |
| Nov 24, 2010 | Siemens 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 |
IYE | K072485 |
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