# K092145: 160MLC Option - Pathway: 510(k) (Traditional) - Applicant: Siemens Medical Solutions USA, Inc. - Decided: Sep 18, 2009 after 65 days - Product code: IYE (Accelerator, Linear, Medical) - Device class: 2 - Regulation: 21 CFR 892.5050 - Recalls of this device: 11 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 10 generations back to K914698 (1992). 46 ancestors in all. 4 later devices descend from it; 1 cites it directly. 0 of 51 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K072485: Artiste MV SA, Siemens Medical Solutions USA, Inc. (2007) Summary page 1. - K060226: Oncor Expression, Siemens Medical Solutions USA, Inc. (2006) Summary page 1. - K082775: Prescision Option, Siemens Medical Solutions USA, Inc. (2009) Summary page 1. ## Most influential descendants - K123812: Coherence RT Therapist Connect Workspace, V2.3, Aria Connectivity Option for Siemens Non-Imaging Systems, Aria Connectiv (2013), 3 descendants of its own - K132935: Artiste Solution with Sys_VC10C and Syngo RT Therapist Workspace, V4.3.1 Upgrade Kit, Aria Connectivity Option for Sieme (2014), 2 descendants of its own - K142434: Artiste Solution, Sys_VC10C, Phase 2 Update with the Syngo RT Therapist & RT Oncologist Workspaces, V4.3.1_MR1 (2014), 1 descendant of its own - K182050: Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation Therapy Therapist v4.3.1_MR3 Patch, syngo Radiation Therapy Oncologist v4.3.1_MR3 Patch (2018), 0 descendants of its own ## Recalls of this device - Apr 3, 2012 · Not classified · Z-1493-2012: Siemens became aware of a potential safety risk related to the behavior of the 160 MLC when using the "Motion Stop" button followed by "Reset" several times during the treatment of one beam or one seg - Apr 15, 2011 · Not classified · Z-2404-2011: Siemens became aware of a potential safety risk related to the behavior of the 160 MLC when using the "Motion Stop" button followed by "Reset" several times during the treatment of one beam or one seg - Mar 5, 13 · Class II · Z-1042-2013: Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testin - Mar 5, 13 · Class II · Z-1038-2013: Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testin - Mar 5, 13 · Class II · Z-1037-2013: Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testin - Mar 5, 13 · Class II · Z-1040-2013: Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testin - Mar 5, 13 · Class II · Z-1041-2013: Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testin - Mar 5, 13 · Class II · Z-1043-2013: Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testin - Mar 5, 13 · Class II · Z-1036-2013: Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testin - Mar 5, 13 · Class II · Z-1039-2013: Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testin - Mar 5, 13 · Class II · Z-1044-2013: Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testin ## Indications for use The intended use of the SIEMENS branded ARTISTE, ONCOR and PRIMUS family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. The linear accelerator is a high-dose and high-dose rate medical linear accelerator optimized for 3D conformal radiation therapy, intensity-modulated radiation therapy (IMRT) and when used in conjunction with a multi-leaf collimator, supports precision radiation therapy treatment. The radiation therapy treatment may include single-session treatment, fractionated radiation therapy treatments, fractionated intensity modulated radiation therapy (IMRT) for lesions, tumors and conditions anywhere in the body where radiation therapy is indicated. Additionally, the SIEMENS branded linear accelerators includes as an optional feature, a 160 leaf multi-leaf collimator that is marketed as 160MLC. The 160MLC is provided to assist the radiation oncologist in the delivery of radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. The indications for use for the 160MLC Option remains unchanged from the previously cleared 160MLC used on the ARTISTE linear accelerator (K072485). The syngo®Suite for Oncology Workspaces includes a number of syngo based software applications whose indication for use include the viewing, processing, filming, and archiving of medical images. The workspaces also permit patient data management, patient selection/setup, patient positioning verification, treatment planning, treatment delivery/verification, and treatment recording. Source page: https://510kreport.com/device/K092145 Methodology: https://510kreport.com/methodology