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 21, 2013 | Siemens Medical Solutions USA, Inc ARTISTE with syngo RT Therapist version 4.3
Product Usage:
The intended use of the SIEMENS branded ARTISTE family of linear accelerator systems is to deliver X-ray photon and electron radiation for Terminated |
IYE | K121295 |
| May 25, 2013 | Elekta, Inc. Integrity 3.0
Product Usage:
The Agility multileaf collimator is indicated for use when additional flexibility is required in conforming the radiation beam to the anatomy to be exposed. Terminated |
IYE | K121328 |
| May 15, 2013 | Varian 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 |
IYE | K100890 |
| Apr 26, 2013 | Siemens Medical Solutions USA, Inc Software correction applies to customers who use the RT Therapist RTT4.2.108 and RT Therapist Connect RTT 4.2.108
on Siemens ARTISTE, ONCOR and PRIMUS systems.
ARTISTE, ONCOR and PRIMUS family of l Terminated |
IYE | K060226 K103606 +1 |
| Apr 23, 2013 | Varian 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 |
IYE | K102024 |
| Apr 16, 2013 | Accuray Incorporated Accuray CyberKnife System Medical Physicist, Robotic Radiosurgery System, Medical charged-particle radiation therapy system, Model: Iris Variable Aperture Collimator P/Ns 028986 and 031777. The CyberK Terminated |
IYE | K122137 |
| Apr 10, 2013 | Siemens Medical Solutions USA, Inc ELEKTA MOSAIQ SW version below 2.41
Product Usage: The intended use of the SIEMENS branded ARTISTE and ONCOR family of linear accelerator systems is to deliver X-ray photon and electron radiation fo Terminated |
IYE | K123230 |
| Apr 2, 2013 | Siemens Medical Solutions USA, Inc SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators;
Model:
Primeview 3i 2 Terminated |
IYE | K060226 K092145 +2 |
| Apr 2, 2013 | Siemens Medical Solutions USA, Inc SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators;
Model:
Primeview 3i 2 Terminated |
IYE | K060226 K092145 +2 |
| Apr 2, 2013 | Siemens Medical Solutions USA, Inc SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators;
Model:
Primeview 3i, P Terminated |
IYE | K060226 K092145 +2 |
| Apr 2, 2013 | Siemens Medical Solutions USA, Inc SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators;
Model:
COHERENCE TH 2. Terminated |
IYE | K060226 K092145 +2 |
| Apr 2, 2013 | Siemens Medical Solutions USA, Inc SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators;
Model:
COHERENCE TH 2. Terminated |
IYE | K060226 K092145 +2 |
| Apr 2, 2013 | Siemens Medical Solutions USA, Inc SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators;
Model:
COHERENCE TH 2. Terminated |
IYE | K060226 K092145 +2 |
| Apr 2, 2013 | Siemens Medical Solutions USA, Inc SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators;
Model:
COHERENCE Impre Terminated |
IYE | K060226 K092145 +2 |
| Apr 2, 2013 | Siemens Medical Solutions USA, Inc SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators;
Model:
COHERENCE TH, Terminated |
IYE | K060226 K092145 +2 |
| Apr 2, 2013 | Siemens Medical Solutions USA, Inc SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators;
Model:
COHERENCE AG T Terminated |
IYE | K060226 K092145 +2 |
| Mar 10, 2013 | Elekta, Inc. Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1
Used as part of radiation therapy treatment process. Terminated |
IYE | K051932 |
| Mar 5, 2013 | Siemens Medical Solutions USA, Inc SIEMENS brand ARTISTE syngo RT Therapist (RTT) version 4.3, ARTISTE Model, Part No. 08162815, Digital linear accelerators, MOSAIQ OIS system, Distributed by SIEMENS Healthcare IM CR RO, CR Radiation O Terminated |
IYE | K121295 |
| Dec 17, 2012 | Varian 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 |
IYE | K093527 |
| Nov 5, 2012 | Philips Medical Systems (Cleveland), Inc. Pinnacle3 VCC P/N 4598 001 41341 REV A, Philips Medical Systems (Cleveland), Inc., Fitchburg, WI.
Pinnacle3 Radiation Therapy Planning System is a computer software package intended to provide suppor Terminated |
IYE | K041577 |
| Nov 1, 2012 | Varian 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 |
IYE | K093527 |
| Oct 30, 2012 | Elekta, Inc. MOSAIQ
MOSAIQ is an image-enabled electronic medical record system (EMR) used for oncology workflow management. It lets users supply electronic patient charts and assemble care plans, order diagnosti Terminated |
IYE | K120067 |
| Sep 19, 2012 | Elekta, Inc. Precise Digital Accelerator
Delivery of radiation to defined target volumes Terminated |
IYE | K051932 |
| Sep 14, 2012 | Varian 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 |
IYE | K081188 K926321 |
| Sep 10, 2012 | Elekta, Inc. Multileaf Collimator
To be used for single or multiple fractions, delivered as static and/or dynamic beams of radiation, in all areas of the body where such treatment is indicated. Terminated |
IYE | K121328 |
| Aug 8, 2012 | Varian 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 |
IYE | K093527 |
| Jul 24, 2012 | Siemens Medical Solutions USA, Inc ARTISTE or ONCOR Digital Linear Accelerators with syngo RT Therapist version 4.2/MOSAIQ OIS Systems and Multiple-X, Manufactured by SIEMENS AG. The ARTISTE and ONCOR family of Linear Accelerators are Terminated |
IYE | K103606 |
| Jul 6, 2012 | Impac Medical Systems Inc MOSAIQ Oncology Information Systems interfaced to Elekta Treatment machines.
An image enabled electronic medical record system used for oncology workflow management.
Manufactured by:
Impac Medical S Terminated |
IYE | K120067 |
| May 23, 2012 | Elekta, Inc. MLCi/MCLi2.
Radiation therapy. Terminated |
IYE | K082122 |
| May 16, 2012 | Varian 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 |
IYE | K111106 |
| May 8, 2012 | Varian 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 |
IYE | K111106 |
| May 8, 2012 | Siemens Medical Solutions USA, Inc Siemens-branded ONCOR" or PRIMUS" linear accelerator with an OPTIVUE" or MVision" imaging system;
Model Numbers: ONCOR Expression 7360717, ONCOR Impression Plus 5857912, ONCOR Avant Garde 5863472, PR Terminated |
IYE | K060226 K993425 |
| May 7, 2012 | 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 3, 2012 | Siemens Medical Solutions USA, Inc Siemens-branded linear accelerator with a 550 TxT Treatment Table with a serial number <_ 1894. Siemens brand ARTISTE, ONCOR and PRIMUS Linear Accelerator systems include the 550 TxT" Treatment Table Terminated |
IYE | K060226 K103606 |
| Mar 21, 2012 | Siemens Medical Solutions USA, Inc MOSAIQ System;
customers with Siemens branded linear accelerators with a COHERENCE RT Therapist workspace version 2.1a and the 3rd party MOSAIQ Oncology Information System.
MOSAIQ Oncology informatio Terminated |
IYE | K090683 K981313 |
| Mar 16, 2012 | Varian 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 |
IYE | K962792 |
| Mar 8, 2012 | Integra LifeSciences Corp Integra InterFix CT Adapter (CTA)
Intended for cranial fixation during CT scanning and
treatment with the TomoTherapy HiArt (Torno) System
The Integra InterFix CT Adapter (CTA) kits are intended for Terminated |
IYE | K072454 |
| Mar 6, 2012 | Varian 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 |
IYE | K111106 |
| Feb 23, 2012 | Siemens Medical Solutions USA, Inc ARTISTE, ONCOR and PRIMUS Linear Accelerators with RT Therapist Workspace, version 4.1. Manufactured by Siemens AG, Kemnath, Germany. The indication is to deliver X-ray, photon and electron radiation Terminated |
IYE | K060226 K072485 +1 |
| Feb 23, 2012 | Varian 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 |
IYE | K050442 K071992 +1 |
| Feb 23, 2012 | Varian 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 |
IYE | K050442 K071992 +1 |
| Feb 23, 2012 | Accuray Incorporated CyberKnife Robotic Radiosurgery System with 4D Planning procedure option of MultiPlan Treatment Planning System, versions 3.0, 3.1, 3.5.1, 3.5.2 and 3.5.3 with Ray-Tracing dose calculation.
Accuray In Terminated |
IYE | K091999 |
| Feb 21, 2012 | Elekta, Inc. Elekta Synergy XVI 4.5 and R4.6
To be used as part of radiation therapy treatment process. Terminated |
IYE | K100115 |
| Feb 3, 2012 | Varian 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 |
IYE | K990085 |
| Jan 17, 2012 | Siemens Medical Solutions USA, Inc Mevatron KDS-2;
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 KD-2;
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 KDS-2;
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 MD-2;
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 M2 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 treatme Terminated |
IYE | K882729 |
| Jan 17, 2012 | Siemens Medical Solutions USA, Inc Mevatron M2 6300;
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 treatme Terminated |
IYE | K882729 |
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