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) |
|---|---|---|---|
| Jan 17, 2012 | Siemens 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 |
IYE | K882729 |
| Jan 17, 2012 | Siemens 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 |
IYE | K882729 |
| Jan 17, 2012 | Siemens 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 |
IYE | K882729 |
| Jan 17, 2012 | Siemens 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 |
IYE | K882729 |
| Jan 17, 2012 | Siemens 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 |
IYE | K882729 |
| Jan 17, 2012 | Siemens 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 |
IYE | K882729 |
| Jan 17, 2012 | Siemens 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 |
IYE | K882729 |
| Jan 17, 2012 | Siemens 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 |
IYE | K882729 |
| Jan 17, 2012 | Siemens 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 |
IYE | K882729 |
| Jan 17, 2012 | Siemens 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 |
IYE | K882729 |
| Jan 17, 2012 | Siemens 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 |
IYE | K993425 |
| Jan 17, 2012 | Siemens 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 |
IYE | K882729 |
| Jan 17, 2012 | Siemens 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 |
IYE | K882729 |
| 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 | Philips 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 |
IYE | K041577 |
| Jan 11, 2012 | Siemens 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 |
IYE | K060226 K103505 |
| Jan 11, 2012 | Siemens 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 |
IYE | K103606 |
| Jan 11, 2012 | Accuray 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 |
IYE | K091999 |
| Dec 1, 2011 | Elekta, Inc. Elekta Synergy XVI X-ray Volume Imaging System
To be used as part of radiation therapy treatment process. Terminated |
IYE | K100115 |
| Dec 1, 2011 | Elekta, Inc. Elekta Synergy XVI R.4.5 and R4.6
ProducT Usage: To be used as part of radiation therapy treatment process. Terminated |
IYE | K100115 |
| 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 |
| Nov 29, 2011 | Elekta, Inc. Elekta Synergy XVI 4.5
Product Usage: Radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner. Terminated |
IYE | K051932 |
| 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 |
| Oct 17, 2011 | Impac 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 |
IYE | K981313 |
| Oct 11, 2011 | Accuray 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 |
IYE | K102650 |
| Oct 11, 2011 | Accuray 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 |
IYE | K102650 |
| Sep 14, 2011 | Varian 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 |
IYE | 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 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 11, 2011 | Siemens 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 |
IYE | K060226 K072485 +1 |
| Aug 10, 2011 | Siemens 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 |
IYE | K080906 |
| Aug 10, 2011 | Varian 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 |
IYE | K033343 K100890 |
| Jul 28, 2011 | Varian 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 |
IYE | K100890 |
| Jul 11, 2011 | Siemens 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 |
IYE | K060226 K072486 +1 |
| Jul 11, 2011 | Varian 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 |
IYE | K033343 K100890 |
| Jul 8, 2011 | Varian 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 |
IYE | K092871 |
| Jul 8, 2011 | Varian 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 |
IYE | K100890 |
| Jul 8, 2011 | Varian 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 |
IYE | K093527 |
| Jun 24, 2011 | Impac 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 |
IYE | K981313 |
| Jun 23, 2011 | Siemens 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 |
IYE | K993425 |
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