# K072485: Artiste MV SA

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Dec 27, 2007 after 114 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 24 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K914698 (1992). 29 ancestors in all.
11 later devices descend from it; 6 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060226: Oncor Expression, Siemens Medical Solutions USA, Inc. (2006) Summary page 1.

## Most influential descendants
- K082775: Prescision Option (2009), 9 descendants of its own
- K090683: Syngo RT Therapist Connect (2009), 7 descendants of its own
- K102671: Syngo RT Therapist Connect Workspace, V4.2 (2010), 5 descendants of its own
- K103606: Artiste Solution with Sys_VB50 Update (2011), 4 descendants of its own
- K092145: 160MLC Option (2009), 4 descendants of its own

## Recalls of this device
- Feb 18, 2020 · Class II · Z-1677-2020: Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy.
- Mar 20, 2019 · Class II · Z-1204-2019: Advisory issued not to disable or bypass the AMP function. Disabling or bypassing the AMP function for reasons of comfort is not advisable may lead to patient or user injury due to collision with LINA
- Feb 14, 2017 · Class II · Z-1488-2017: Software update
- Jan 25, 2017 · Class II · Z-1212-2017: Siemens became aware of Incorrect values for the rotational collimator position displayed due to mechanical problems of the sensor slide. In addition, there are improper weld seam at the overhead susp
- Dec 19, 2014 · Class II · Z-1059-2015: A hardware update to replace the old PCB Assembly, Head Driver-G41 with PCB with overcurrent protection as a result of reports of the electric board inside the gantry showing signs of overheating, inc
- Dec 2, 2014 · Class II · Z-0980-2015: Use of any unauthorized third-party components on Siemens LINACs may lead to patient or operator injury, damage to the LINAC, and can potentially compromise customer warranty. The dark current dose mu
- Jun 17, 2014 · Class II · Z-2180-2014: Siemens became aware of a potential issue with the syngo RT Therapist 4.3.SP1 and syngo RT Oncologist 4.3SP1 software applications running on Siemens brand LINAC systems that may experience sporadic s
- May 28, 2014 · Class II · Z-2174-2014: A safety risk exists with automatically sequenced treatment technique using the SIMTEC Auto Field Option where automatic movements of the gantry and the tabletop during an auto-sequenced treatment hav
- Apr 1, 2014 · Class II · Z-1652-2014: Siemens Radiation Oncology became aware that customers may be using the Siemens Linear Accelerator in combination with stereotactic accessories which have not been validated as being compatible with S
- Apr 1, 2014 · Class II · Z-1645-2014: Table may lose calibration during patient treatment, which may cause the possibility of mistreatment.
- Oct 23, 2013 · Class II · Z-0438-2014: A safety risk regarding a potentially existing dark current radiation phenomenon on the Linear Accelerator (LINAC) in combination with IMRT or mARC (rotational IMRT) treatments using unflat (flattenin
- Jan 22, 2012 · Not classified · Z-1092-2012: Software upgrade to installed base to the latest release of the RT Therapist version 4.1.144 which corrects multiple safety issues that could lead to patient mistreatment.
- Jun 3, 2011 · Not classified · Z-3003-2011: A potential safety issue was discovered when a pause for an imaging segment is inserted (where an imaging segment does not exist) with the ARTISTE and RT Therapist 4.1 system will continue to the next
- Dec 3, 2010 · Not classified · Z-1422-2011: The firm become aware of a potential issue with ARTISTE system that may result in patient injury should the positioner belt break, and the cam disc (secondary safety mechanism) is not installed and if
- Jun 29, 2010 · Not classified · Z-1523-2011: A software problem that has the potential for data loss during the transfer of treatment records to the OIS, which may not be recorded in MOSAIQ, and subsequently may lead to mistreatment.
- Jan 22, 2010 · Not classified · Z-0449-2011: The robotic lift armature shaft may break and allow the Flat Panel Positioner with the digital flat panel imager to fall into the Flat Panel cradle. If the positioner is over a patient, there is a pot
- Sep 10, 2009 · Not classified · Z-0121-2010: A failed data transfer is possible that may result in data not being recorded in the interfaced system. Siemens Medical Solutions, Inc. USA became aware of this potential issue with its ARTISTE Linear
- Aug 21, 2009 · Not classified · Z-1970-2011: When editing the note type of a previously entered note, then reverting to the original type, data may be lost.
- Jul 30, 2009 · Not classified · Z-1064-2011: Potential for Mistreatment-- when treatment plans intended for non-ARTISTE machinese are loaded, if the plans contain unspecified beam parameters, attributes or unknown block codes, the therapy system
- Apr 9, 2009 · Not classified · Z-1888-2009: Unexpected treatment plan alteration-- Software issue may result in unintended modifications to treatment
- Dec 20, 2008 · Not classified · Z-0949-2009: The range of tolerance is to high for the accessory holder, therefore, Wedges and other accessories do not latch to the locking mechanism correctly.
- Oct 23, 2008 · Not classified · Z-0857-2009: Under certain conditions, the flat panel may move unexpectedly and collide with the patient.
- Oct 23, 2008 · Not classified · Z-0927-2009: If a plan contains a sequence of beams, including at least 1 ARC treatment beam and if during the setup stage of a beam following an ARC beam in the delivery sequence a termination occurs, and the use
- Jul 4, 2008 · Not classified · Z-0116-2009: Three issues: unexpected rotation of gantry, unexpected movement of table between beams during patient setup, and single exposure images will be overwritten by double exposure images.

## Indications for use
The intended use of the ARTISTE MV SAT M linear accelerator system is to deliver x-ray radiation for therapeutic treatment of cancer. The ARTISTE MV SATM includes an Electronic Portal Imaging Device (EPID), a 160 leaf multi-leaf collimator, and the syngoTM RT Therapist Express Workspace with MVisionTM. The syngoTM RT Therapist Express Workspace is a software application that uses syngoTM based applications with these embedded features: • patient data management, selection and setup by use of a local, on-board database, • treatment delivery/verification and treatment recording by use of on-board applications, • Megavoltage Cone Beam acquisition method for acquiring projection data for 3D reconstruction. • Patient positioning verification by use of the OPTIVUE imaging system, including MVisionTM(Cone Beam acquisition and reconstruction and the Adaptive Targeting application).

Source page: https://510kreport.com/device/K072485
Methodology: https://510kreport.com/methodology