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) |
|---|---|---|---|
| Sep 29, 2008 | Siemens Medical Solutions USA, Inc Siemens Medical Solutions, Mevatron KD-2 Digital Linear Accelerator, part number 8515520 equipped with a Digital Electron Variable Applicator (DEVA, Part Number 8485971) with available energy of 6 MeV Terminated |
IYE | K862339 |
| Sep 18, 2008 | Civco Medical Instruments Inc Isoloc Software, Version 6.6, 6.5 and 6.0. Part Number MT-NW-425-520. Software computer hard disc reads "ISOLOC 6.6 Copyright NMPE Copyright 1997-2004 NMPE Build #10302006 CIVCO MEDICAL SOLUTIONS
Terminated |
IYE | K904908 |
| Sep 17, 2008 | Varian Medical Systems Oncology Systems Varian Medical Systems Eclipse device, model H48, Version 6.5 is used to plan photon and electron radiation therapy treatments. Terminated |
IYE | K010975 |
| Sep 17, 2008 | Siemens Medical Solutions USA, Inc Radiation therapy system - PRIMEVIEW 3i System 2.1 equipped with Coherence Therapist RTT2.1 or Primeview 3i R2.1, part number 8147675. Medical charged particle Radiation therapy system, part of the f Terminated |
IYE | K060226 |
| Sep 17, 2008 | Siemens Medical Solutions USA, Inc Radiation therapy system - Coherence Therapist System 2.1 equipped with Coherence Therapist RTT2.1 or Primeview 3i R2.1, part number 8147667. Medical charged particle Radiation therapy system, part o Terminated |
IYE | K060226 |
| Sep 17, 2008 | Siemens Medical Solutions USA, Inc Radiation therapy system - PRIMEVIEW 3i System 2.0 equipped with Coherence Therapist RTT2.1 or Primeview 3i R2.1, part number 8139847. Medical charged particle Radiation therapy system, part of the f Terminated |
IYE | K060226 |
| Sep 17, 2008 | Siemens Medical Solutions USA, Inc Radiation therapy system - Coherence Therapist 2.0 equipped with Coherence Therapist RTT2.1 or Primeview 3i R2.1, part number 8139839. Medical charged particle Radiation therapy system, part of the f Terminated |
IYE | K060226 |
| Sep 17, 2008 | Siemens Medical Solutions USA, Inc Radiation therapy system - Syngo Based WS for 3rd party V&R equipped with Coherence Therapist RTT2.1 or Primeview 3i R2.1, part number 7345437. Medical charged particle Radiation therapy system, part Terminated |
IYE | K060226 |
| Sep 17, 2008 | Siemens Medical Solutions USA, Inc Radiation therapy system - Impression Therapist 3rd party V&R equipped with Coherence Therapist RTT2.1 or Primeview 3i R2.1, part number 7345429. Medical charged particle Radiation therapy system, pa Terminated |
IYE | K060226 |
| Sep 17, 2008 | Siemens Medical Solutions USA, Inc Radiation therapy system - AG Therapist 3rd party V&R equipped with Coherence Therapist RTT2.1 or Primeview 3i R2.1, part number 7345411. Medical charged particle Radiation therapy system, part of th Terminated |
IYE | K060226 |
| Sep 17, 2008 | Siemens Medical Solutions USA, Inc Radiation therapy system - PRIMEVIEW 3i System equipped with a Coherence Therapist RTT2.1 or Primeview 3i R2.1, part number 7341428. Medical charged particle Radiation therapy system, part of the fir Terminated |
IYE | K060226 |
| Sep 17, 2008 | Siemens Medical Solutions USA, Inc Radiation therapy system - Coherence Impression Therapist System equipped with a Coherence Therapist RTT2.1 or Primeview 3i R2.1 part number 7341410. Medical charged particle Radiation therapy system Terminated |
IYE | K060226 |
| Sep 17, 2008 | Siemens Medical Solutions USA, Inc Radiation therapy system - Coherence AG Therapist Part number 5863506 and Therapist system Part number 7339125, equipped with a Coherence Therapist RTT2.1 or Primeview 3i R2.1. This is a medical cha Terminated |
IYE | K060226 |
| Sep 17, 2008 | Accuray Inc CyberKnife Robotic Radiosurgery System radiation therapy device with Multiplan treatment Planning Software versions 1.5.2 and higher. Terminated |
IYE | K072504 |
| Sep 16, 2008 | Varian Medical Systems Oncology Systems Varian Medical Systems FastPlan, versions 5.5 and 5.5.1, model number HZ3, manufactured by Varian Medical Systems, Palo Alto, CA The product is a radiation treatment planning system. Terminated |
IYE | K962792 |
| Sep 16, 2008 | Accuray Inc Accuracy Cyberknife Robotic Radiosurgery System, medical charged particle radiation therapy device. Model number 020700 (axum/standard treatment couch) and 021756 hand controller. The device is indi Terminated |
IYE | K072504 |
| Sep 4, 2008 | Varian Medical Systems Oncology Systems Varis Aria Radiation Oncology Version 8.1, manufactured by Varian Medical Systems, Palo Alto, CA The device is designed to assist the operator in providing accurate treatment setups for each patient Terminated |
IYE | K001643 |
| Sep 4, 2008 | Siemens Medical Solutions USA, Inc Siemens Linear Medical Accelerators equipped with COHERENCE Therapist R2.1 and Primeview 3 i R 2.1. Part numbers 5863506, 7339125, 7341410, 7341428, 7345411, 7345429, 7345437, 8139839, 8139847, 81476 Terminated |
IYE | K060226 |
| Aug 24, 2008 | TomoTherapy Incorporated TomoTherapy Hi-Art System with software versions 3.0 and 3.1 - Radiation Therapy System. The device is intended to be used as an integrated system for the planning and delivery of intensity modulate Terminated |
IYE | K060912 |
| Aug 20, 2008 | Siemens Medical Solutions USA, Inc Medical charged-particle radiation therapy system. Siemens Linear Medical Accelerators equipped with COHERENCE Therapist R2.0 and Oncologist R2.0. Product update, TH 030//07/S. The COHERENCE Therap Terminated |
IYE | K031764 |
| Aug 16, 2008 | Impac Medical Systems Inc SEQUENCER, MOSAIQ versions 1.3 and 1.4 with Elekta and Siemens Machines, Model number 40003-001000-RO, Manufactured by IMPAC Medical Systems, Sunnyvale, CA.
Used to facilitate the delivery of defined Terminated |
IYE | K981313 |
| Aug 15, 2008 | Varian Medical Systems Oncology Systems Varian Medical Systems On-Board Imager, Versions 1.0.15 and 1.2.05 Imaging Accessory to Medical Linear Accelerator. The On-Board Imager Device is used for verification of correct patient position in Terminated |
IYE | K040192 K041519 +1 |
| Aug 2, 2008 | Varian Medical Systems Oncology Systems High-Definition 120 MultiLeaf Collimator, Medical charged-particle radiation therapy system; Software Version 7.0; Product Code: H56; Accessory to Medical Linear Accelerator. Terminated |
IYE | K071992 |
| May 21, 2008 | Med Tec Inc dba CIVCO Medical Solutions Fiducial Markers (0.9 x 3 mm) Soft tissue gold markers, Medical charged-particle radiation therapy system; Part Number: MT-NW-887-809, CIVCO Medical Solutions (MEDTEC), Orange City, IA 51041. Terminated |
IYE | K071614 |
| May 21, 2008 | Med Tec Inc dba CIVCO Medical Solutions Fiducial Markers (2mm spheres) Bone gold markers, Medical charged-particle radiation therapy system; Part Number: MT-NW-887-805, CIVCO Medical Solutions (MEDTEC), Orange City, IA 51041. Terminated |
IYE | K071614 |
| May 21, 2008 | Civco Medical Instruments Inc MT-APSD-2.4 Type-S Thermoplastic Mask, Medical charged-particle radiation therapy system; Disposable non-sterile (43.2cm) standard perforated thermoplastic head, neck and shoulder mask (2.4mm), 1 dev Terminated |
IYE | None listed |
| Apr 30, 2008 | Siemens Medical Solutions USA, Inc Siemens Primeview 3i 2.1 medical charged-particle radiation therapy system, Part No: 8147675, with software version 3i. Siemens AG, Concord, CA. Terminated |
IYE | K060226 |
| Apr 30, 2008 | Siemens Medical Solutions USA, Inc Siemens Coherence Therapist 2.1 medical charged-particle radiation therapy system, Part No: 8147667, with software version 2. Siemens AG, Concord, CA. Terminated |
IYE | K060226 |
| Apr 30, 2008 | Siemens Medical Solutions USA, Inc Siemens Primeview 3i 2.0 medical charged-particle radiation therapy system, Part No: 8139487, with software version 3i 2.0. Siemens AG, Concord, CA. Terminated |
IYE | K060226 |
| Apr 30, 2008 | Siemens Medical Solutions USA, Inc Siemens Coherence Therapist 2.0 medical charged-particle radiation therapy system, Part No: 8139839, with software version 2.1. Siemens AG, Concord, CA. Terminated |
IYE | K060226 |
| Apr 30, 2008 | Siemens Medical Solutions USA, Inc Siemens Syngo based WS 3rd Party V&R medical charged-particle radiation therapy system, Part No: 7345437. Siemens AG, Concord, CA. Terminated |
IYE | K060226 |
| Apr 30, 2008 | Siemens Medical Solutions USA, Inc Siemens Impression Therapist 3rd Party V&R medical charged-particle radiation therapy system, Part No: 7345429. Siemens AG, Concord, CA. Terminated |
IYE | K060226 |
| Apr 30, 2008 | Siemens Medical Solutions USA, Inc Siemens AG Therapist 3rd Party V&R medical charged-particle radiation therapy system, Part No: 7345411. Siemens AG, Concord, CA. Terminated |
IYE | K060226 |
| Apr 30, 2008 | Siemens Medical Solutions USA, Inc Siemens Primeview 3i medical charged-particle radiation therapy system, Part No: 7341428, with software version 3i. Siemens AG, Concord, CA. Terminated |
IYE | K060226 |
| Apr 30, 2008 | Siemens Medical Solutions USA, Inc Siemens Coherence Impression Therapist system, Part No: 7341410, medical charged-particle radiation therapy system with software version 2.1. Siemens AG, Concord, CA. Terminated |
IYE | K060226 |
| Apr 30, 2008 | Siemens Medical Solutions USA, Inc Siemens Coherence Therapist system, Part No: 7339125, medical charged-particle radiation therapy system with software version 2.1. Siemens AG, Concord, CA. Terminated |
IYE | K060226 |
| Apr 30, 2008 | Siemens Medical Solutions USA, Inc Siemens Coherence AG Therapist, Part No: 5863506, medical charged-particle radiation therapy system with software version 2.1. Siemens AG, Concord, CA. Terminated |
IYE | K060226 |
| Apr 2, 2008 | Siemens Medical Solutions USA, Inc Mevatron KDS-2 Medical Linear Accelerator, Material Number: 09822685, with control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Manufactured by Siemens Medical Solutions USA, Inc, Concord, CA Terminated |
IYE | None listed |
| Apr 2, 2008 | Siemens Medical Solutions USA, Inc Mevatron KDS-2 Medical Linear Accelerator, Material Number: 09411588, with control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Manufactured by Siemens Medical Solutions USA, Inc, Concord, CA Terminated |
IYE | None listed |
| Apr 2, 2008 | Siemens Medical Solutions USA, Inc Mevatron MD2 Medical Linear Accelerator, Material Number: 09401654, with control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Manufactured by Siemens Medical Solutions USA, Inc, Concord, CA Terminated |
IYE | None listed |
| Apr 2, 2008 | Siemens Medical Solutions USA, Inc MEVATRON M-2 6300 Medical Linear Accelerator, Material Number: 09401316 with control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Manufactured by Siemens Medical Solutions USA, Inc, Concord, C Terminated |
IYE | None listed |
| Apr 2, 2008 | Siemens Medical Solutions USA, Inc Primart MX Medical Linear Accelerator, Material Number: 05500371, with control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Manufactured by Siemens Medical Solutions USA, Inc, Concord, CA Terminated |
IYE | None listed |
| Apr 2, 2008 | Siemens Medical Solutions USA, Inc Mevatron KDS-2 Medical Linear Accelerator, Material Number: 9822693, with control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Manufactured by Siemens Medical Solutions USA, Inc, Concord, CA Terminated |
IYE | K882729 |
| Apr 2, 2008 | Siemens Medical Solutions USA, Inc Mevatron KD-2 Medical Linear Accelerator, Material Number: 8515520, with control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Manufactured by Siemens Medical Solutions USA, Inc, Concord, CA Terminated |
IYE | K882729 |
| Apr 2, 2008 | Siemens Medical Solutions USA, Inc Oncor Expression Medical Linear Accelerator, Material Number: 07360717, with control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Manufactured by Siemens Medical Solutions USA, Inc, Concord, C Terminated |
IYE | K060226 |
| Apr 2, 2008 | Siemens Medical Solutions USA, Inc Oncor Avante-Garde Medical Linear Accelerator, Material Number: 5857920, with control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Manufactured by Siemens Medical Solutions USA, Inc, Concord, Terminated |
IYE | K031764 |
| Apr 2, 2008 | Siemens Medical Solutions USA, Inc Oncor Impression Medical Linear Accelerator, Material Number : 5857920, with control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Manufactured by Siemens Medical Solutions USA, Inc, Concord, C Terminated |
IYE | K993425 |
| Apr 2, 2008 | Siemens Medical Solutions USA, Inc Oncor Impression Plus Medical Linear Accelerator, Material Number : 5857912, with control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Manufactured by Siemens Medical Solutions USA, Inc, Conco Terminated |
IYE | K993425 |
| Apr 2, 2008 | Siemens Medical Solutions USA, Inc Primus Plus Medical Linear Accelerator, Material Number : 4504200, with control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Manufactured by Siemens Medical Solutions USA, Inc, Concord, CA Terminated |
IYE | K993425 |
| Apr 2, 2008 | Siemens Medical Solutions USA, Inc Mevatron KD2 Medical Linear Accelerator, Material Number: 01940753, with control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Manufactured by Siemens Medical Solutions USA, Inc, Concord, CA Terminated |
IYE | K862339 |
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