# K031764: Oncor Avant-Garde with Coherence Workspaces

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Sep 5, 2003 after 88 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 17 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K914698 (1992). 25 ancestors in all.
16 later devices descend from it; 3 cite it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993425: Primus, Siemens Medical Solutions USA, Inc. (1999) Summary page 1.
- K862339: Mevatron KD-2, Siemens Medical Laboratories, Inc. (1986) Summary page 1.
- K903139: Beamview & Beamview Plus (Aka Project 743), Siemens Medical Laboratories, Inc. (1990) Summary page 1.
- K003636: Portalvision, Varian Medical Systems, Inc. (2001)
- K953894: Siemens Multileaf Collimator, Siemens Medical Solutions USA, Inc. (1995) Summary page 1.
- K022036: Siemens Virtual Simulation (Vsim), Siemens Medical Solutions USA, Inc. (2002) Summary page 2.
- K010938: Syngo Multimodality Workstation, Siemens Medical Solutions USA, Inc. (2001) Summary page 2.
- K972275: Lantis Treatstation, Siemens Medical Solutions USA, Inc. (1997) Summary page 1.

## Most influential descendants
- K060226: Oncor Expression (2006), 13 descendants of its own
- K072485: Artiste MV SA (2007), 11 descendants of its own
- 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

## Recalls of this device
- 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, 2018 · Class II · Z-1398-2018: Control Console software has been updated to reduce the risk for collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the treatment table.
- Feb 14, 2017 · Class II · Z-1490-2017: Software update
- Jan 25, 2017 · Class II · Z-1213-2017: 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
- Aug 5, 2015 · Class II · Z-2812-2015: A software fix has been released to prevent automatic movement resulting in a collision safety risk for patients.
- May 5, 2015 · Class II · Z-0168-2016: potential safety risk of collision of the LINAC gantry with the patient or the treatment table in case of automatically sequenced treatment delivery techniques using SIMTEC" Auto Field Sequence Option
- 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
- 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-1645-2014: Table may lose calibration during patient treatment, which may cause the possibility of mistreatment.
- May 29, 2013 · Class II · Z-1663-2013: The information regarding the FILM Mode calibration may have been considered difficult to interpret when translated. SIEMENS HEALTHCARE CR / RADIATION ONCOLOGY had become aware that this issue may hav
- Nov 4, 2010 · Not classified · Z-2642-2011: The firm has become aware of a potential issue that may result in a service engineer receiving an electrical shock should the connector cable housing become unfastened from the chassis.
- 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.
- Jan 11, 2008 · Not classified · Z-1399-2008: Linear accelerator gantry may rotate in an unexpected direction and may cause patient injury on impact.
- Oct 3, 2007 · Not classified · Z-1769-2008: Software. The firm issued an Advisory Letter Update instruction TH030/07/S as a result of a complaint that images viewed in the device may shift, which could result in mistreatment. The advisory alert
- Mar 23, 2007 · Not classified · Z-0380-2008: Product's collision detection system may not be sensitive enough to trigger a stop action without a significant amount of force.
- Mar 22, 2007 · Not classified · Z-0164-2008: Mistreatment of radiation therapy due to inadvertent parameter changes or miss-calibration in Service Mode. The miss-calibration can affect the beam profile and Virtual Wedge angle. This leads to pati

## Indications for use
The intended use of the ONCOR Avant-Garde linear accelerator system is to deliver x-ray radiation for therapeutic treatment of cancer. The ONCOR Avant-Garde includes an Electronic Portal Imaging Device (EPID) that will be marketed as OPTIVUE and is used for the verification of the treatment field and shielding blocks in relation to patient positioning markers and/or anatomical landmarks in radiotherapy treatment. OPTIVUE will also allow for verification of the exit dose in radiotherapy treatment. Additionally, the ONCOR Avant-Garde includes an 82 leaf multi-leaf collimator that will be marketed as OPTIFOCUS. The OPTIFOCUS MLC 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. In a static mode, the MLC performs the same function as the customized shadow blocks. In a dynamic mode, a series of MLC leaf positions can be indexed to either dose fraction or gantry angle to create a changing beam shape while the radiation beam is on to create a three dimensional dose distribution. The COHERENCE Workspaces (Therapist and Oncologist) encompasses a number of syngo software applications for viewing, processing, filming, and archiving of medical images. The COHERENCE Therapist and Oncologist Workspaces are two of the software applications that are offered on the syngo workstation (K010938). COHERENCE Therapist Workspace is included in the ONCOR Avant-Garde product. The Therapist Workspace permits patient data management, patient selection/setup, patient positioning verification, treatment delivery/verification, and treatment recording. The COHERENCE Oncologist Workspace permits localization, contouring, image conditioning, and review of treatment parameters. In addition, it includes tools and administrative functions to aid in the diagnosis, staging, and prescription of radiation therapy.

Source page: https://510kreport.com/device/K031764
Methodology: https://510kreport.com/methodology