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)
Apr 2, 2008Siemens Medical Solutions USA, Inc
Mevatron M2/PRIMUS MID Medical Linear Accelerator, Material Number: 019490035, with control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Manufactured by Siemens Medical Solutions USA, Inc, Con
Terminated
IYENone listed
Feb 19, 2008Siemens Medical Solutions USA, Inc
Siemens Mevatron Linear Accelerator Systems; Mevatron M 7440, Part No.: 5672977; Mevatron M 6700, Part No.: 5693908; Mevatron M 6730, Part No.: 5694005; Mevatron M 7140, Part No.: 5694104; Mevatron
Terminated
IYEK882729
Feb 19, 2008Siemens Medical Solutions USA, Inc
Siemens Mevatron Linear Accelerator Systems: KD2, K 7767, K 8067, KD, KDS and KDS2, Mevatron KD2, Part No.: 1940753; Mevatron KD2, Part No.: 08515520; Mevatron KD2-Part No.: 9822685; Mevatron K 7767,
Terminated
IYEK862339
Feb 19, 2008Siemens Medical Solutions USA, Inc
Siemens Primus Linear Accelerator System, PRIMART MX Linear Accelerator System; PRIMUS Mid, Part Number:1940035 and PRIMART MX, Part Number: 5500371, Siemens Medical Solutions USA, Inc., Concord, CA
Terminated
IYEK993425
Feb 15, 2008Varian Medical Systems Inc
Varian brand VARiS 1.4g (Medical Charged Particle Radiation Therapy System, Record and Verify System); Linear Accelerator with RTP Exchange v6.2, v6.6, & v8.0, All Models; Varian Medical Systems, Palo
Terminated
IYEK001643
Feb 14, 2008Siemens Medical Solutions USA, Inc
Siemens Mevatron M-2 PRIMUS hi-energy Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position) Model Number 4504200, Siemens Medical Solutions, Concord, CA 94520
Terminated
IYEK993425
Feb 14, 2008Siemens Medical Solutions USA, Inc
Siemens Mevatron M-2 PRIMUS mid-energy Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position) Model Number :1940035, Siemens Medical Solutions, Concord, CA 94520
Terminated
IYEK993425
Feb 14, 2008Siemens Medical Solutions USA, Inc
Siemens Mevatron K-2 Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position) Model Number: 1940753, Siemens Medical Solutions, Concord, CA 94520
Terminated
IYEK862339
Feb 14, 2008Siemens Medical Solutions USA, Inc
Seimens Mevatron M-2 6300 Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position) Model Number: 9401316, Siemens Medical Solutions, Concord, CA 94520
Terminated
IYEK882729
Feb 14, 2008Siemens Medical Solutions USA, Inc
Seimens Mevatron M-2 6700 Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position) Model Number 9401407, Siemens Medical Solutions, Concord, CA 94520
Terminated
IYEK882729
Feb 14, 2008Siemens Medical Solutions USA, Inc
Siemens Mevatron MDX-2 Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position) Model number 9401746, Siemens Medical Solutions, Concord, CA 94520
Terminated
IYEK882729
Feb 14, 2008Siemens Medical Solutions USA, Inc
Seimens Mevatron KD-2 Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position) Model Number: 9822685, Siemens Medical Solutions, Concord, CA 94520
Terminated
IYEK862339
Feb 14, 2008Siemens Medical Solutions USA, Inc
Siemens Mevatron KDS-2 Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position) Model Number 9822693 and 9411588, Siemens Medical Solutions, Concord, CA 94520
Terminated
IYEK862339
Feb 14, 2008Siemens Medical Solutions USA, Inc
Siemens Mevatron M-2 6740 Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position)Model Number: 9401506, Siemens Medical Solutions, Concord, CA 94520
Terminated
IYEK882729
Feb 14, 2008Siemens Medical Solutions USA, Inc
Siemens Mevatron MD2 Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position) Model Number: 09401654, Siemens Medical Solutions, Concord, CA 94520
Terminated
IYEK882729
Feb 14, 2008Siemens Medical Solutions USA, Inc
Siemens Mevatron KD2 Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position) Model Number:08515520, Siemens Medical Solutions, Concord, CA 94520
Terminated
IYEK862339
Feb 14, 2008Varian Medical Systems Inc
Varian brand Clinac, Accelerator, Linear, Medical charged-particle radiation therapy system; Model: Low Energy Clinacs with one or more of the following options: -- BrainLAB micro MLC -- Stereotacti
Terminated
IYEK070094
Feb 14, 2008Varian Medical Systems Inc
Varian brand Clinac, Accelerator, Linear, Medical charged-particle radiation therapy system: Model: High Energy Clinacs with one or more of the following options: -- BrainLAB micro MLC, -- 6MV SRS ph
Terminated
IYEK070094
Jan 29, 2008Varian Medical Systems Inc
Varian Real-Time Position Management System (RPM), A Respiratory Gating System; Version 1.7.3, All Models; Varian Medical Systems, Palo Alto, CA 94304
Terminated
IYEK063270
Dec 1, 2007Siemens Medical Solutions USA, Inc
Siemens, Mevatron M2 Primus, Part No.: 19 40 035, Mid-Energy Medical Charge particle radiation therapy system, with pre-R2.0 Optivue Flat Panel Positioners, Siemens Medical, Concord, CA 94520
Terminated
IYENone listed
Dec 1, 2007Siemens Medical Solutions USA, Inc
Siemens, ONCOR Avante Garde, Part No.: 58 63 472,Medical Charge particle radiation therapy system, with pre-R2.0 Optivue Flat Panel Positioners, Siemens Medical, Concord, CA 94520
Terminated
IYENone listed
Dec 1, 2007Siemens Medical Solutions USA, Inc
Siemens, Oncor Impression, Part No.: 58 57 920, Medical Charge particle radiation therapy system,with pre-R2.0 Optivue Flat Panel Positioners, Siemens Medical, Concord, CA 94520
Terminated
IYENone listed
Dec 1, 2007Siemens Medical Solutions USA, Inc
Siemens, Oncor Impression Plus, Part No.: 58 57 912, Medical Charge particle radiation therapy system,with pre-R2.0 Optivue Flat Panel Positioners, Siemens Medical, Concord, CA 94520
Terminated
IYENone listed
Dec 1, 2007Siemens Medical Solutions USA, Inc
Siemens, Mevatron M2/PRIMUS Plus, Part No.: 45 04 200, High EnergyMedical Charge particle radiation therapy system with pre-R2.0 Optivue Flat Panel Positioners, Siemens Medical, Concord, CA 94520
Terminated
IYEK031764
K993425
Nov 9, 2007Siemens Medical Solutions USA, Inc
PRIMUS Plus,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBER: 4504200,MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Concord,
Terminated
IYEK993425
Nov 9, 2007Siemens Medical Solutions USA, Inc
MEVATRON M2/PRIMUS Mid,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBER: 1940035, MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nelson Av
Terminated
IYEK993425
Nov 9, 2007Siemens Medical Solutions USA, Inc
ONCOR IMPRESSION,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBER: 5857920, MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Con
Terminated
IYEK993425
Nov 9, 2007Siemens Medical Solutions USA, Inc
ONCOR IMPRESSION Plus,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBER: 5857912, MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nelson Ave
Terminated
IYEK993425
Nov 9, 2007Siemens Medical Solutions USA, Inc
ONCOR Expression,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBERS: 7360204 and 7360717, MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Ne
Terminated
IYEK060226
Nov 9, 2007Siemens Medical Solutions USA, Inc
ONCOR Avant Garde,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBER: 5863472,MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Con
Terminated
IYEK031764
Nov 9, 2007Siemens Medical Solutions USA, Inc
MEVATRON MDX-2,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBER: 9401746,MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Concor
Terminated
IYEK882729
Nov 9, 2007Siemens Medical Solutions USA, Inc
MEVATRON MD-2,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBER: 9401654,MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Concord
Terminated
IYEK882729
Nov 9, 2007Siemens Medical Solutions USA, Inc
MEVATRON M-2 6740,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBER: 9401506,MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Con
Terminated
IYEK882729
Nov 9, 2007Siemens Medical Solutions USA, Inc
MEVATRON M-2 6700,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBER: 9401407,MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Con
Terminated
IYEK882729
Nov 9, 2007Siemens Medical Solutions USA, Inc
MEVATRON M-2 6300,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBER: 9401316,MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Con
Terminated
IYEK882729
Nov 9, 2007Siemens Medical Solutions USA, Inc
MEVATRON KDS-2,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBERS: 9411588 and 9822693,MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nelso
Terminated
IYEK882729
Nov 9, 2007Siemens Medical Solutions USA, Inc
MEVATRON KDS,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBER: 9401522, MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Concord
Terminated
IYEK882729
Nov 9, 2007Siemens Medical Solutions USA, Inc
MEVATRON KD-2,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator), MODEL NUMBERS: 8515520 and 9822685, MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nels
Terminated
IYEK882729
Nov 9, 2007Siemens Medical Solutions USA, Inc
MEVATRON KD2,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBER: 1940753, MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Concord
Terminated
IYEK882729
Aug 29, 2007Varian Medical Systems Inc
Varian On-Board Imager Device versions 1.2 and 1.3, when used with Cone Beam Computed Tomography. Medical Linear Accelerator.
Terminated
IYEK040192
K041519 +1
Aug 9, 2007Northwest Medical Physics Equipment Inc
ISOLOC Software Version 4.2, Part Number NT-NW-425-520. Image guided radiation treatment software.
Terminated
IYEK904908
Aug 8, 2007Northwest Medical Physics Equipment Inc
ISOLOC Software Version 6.0, Part Number NT-NW-425-520. Localization software for radiotherapy treatment system.
Terminated
IYEK904908
Aug 8, 2007Northwest Medical Physics Equipment Inc
ISOLOC Software Version 6.0, Localization software for determining treatment machine position (to position patients) for high accuracy radiotherapy.
Terminated
IYEK904908
Aug 8, 2007Northwest Medical Physics Equipment Inc
ISOLOC Software Versions 6.0 and 4.2. Part Number NT-NW-425-520. Image guided radiotherapy treatment software.
Terminated
IYEK904908
Aug 8, 2007Northwest Medical Physics Equipment Inc
ISOLOC 4.2 Software Part Number NT-NW-425-520. Image guided radiation treatment software.
Terminated
IYEK904908
Aug 8, 2007Northwest Medical Physics Equipment Inc
ISOLOC 6.5 Software Part Number NT-NW-425-520. Software for radiotherapy treatment.
Terminated
IYEK904908
Aug 8, 2007Northwest Medical Physics Equipment Inc
Isoloc software Versions 6.5 and 4.5, Part Number NT-NW-425-520. Software for image guided radiation therapy.
Terminated
IYEK904908
Jul 12, 2007Varian Medical Systems Inc
Varian Medical Systems Clinac Medical Linear Accelerator. Clinac 600 C &C/D, Clinac 2100 C, C/D & EX and Clinac 2300 C &C/D
Terminated
IYEK862645
K913119
Jun 28, 2007Varian Medical Systems Inc
LINAC Scapel Treatment Planning System, incorporating FastPlan software versions 4.0, 5.0, 5.0.1, 5.1, 5.1.1.
Terminated
IYENone listed
Jun 6, 2007Varian Medical Systems Oncology Systems
FramelessArray software, Version 1.0. ; Medical Device firmware incorporated with the RadioCamera Extracranial System, distributed by Varian Medical System, Palo Alto, CA.
Terminated
IYENone listed

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