# K060226: Oncor Expression

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Mar 15, 2006 after 44 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 72 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K914698 (1992). 28 ancestors in all.
13 later devices descend from it; 7 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)
- K031764: Oncor Avant-Garde with Coherence Workspaces, Siemens Medical Solutions USA, Inc. (2003) Summary page 1.
- K993425: Primus, Siemens Medical Solutions USA, Inc. (1999) Summary page 1.
- K040970: Leonardo, Siemens Medical Systems, Inc. (2004) Summary page 1.
- K040347: Siremobil Iso-C 3D, Siemens Medical Systems, Inc. (2004) Summary page 1.

## Most influential descendants
- 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
- K103606: Artiste Solution with Sys_VB50 Update (2011), 4 descendants of its own

## Recalls of this device
- Jul 10, 2019 · Class II · Z-2198-2019: Potentially affected by the Microsoft Windows Remote Desktop Protocol (RDP) vulnerability
- 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-1400-2018: 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, 2018 · Class II · Z-1399-2018: 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-1491-2017: Software update
- Jan 25, 2017 · Class II · Z-1214-2017: 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
- Nov 19, 2014 · Class II · Z-0984-2015: There may be an existing dark current phenomenon on ARTISTE LINAC in combination with IMRT or mARC treatments using unflat beams. Software issue.
- Oct 23, 2013 · Class II · Z-0437-2014: 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
- 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
- Apr 4, 2013 · Class II · Z-1182-2013: Software update to fix multiple safety related issues.
- Apr 4, 2012 · Not classified · Z-1494-2012: The firm became aware of a potential issue with Siemens-branded ONCOR or PRIMUS linear accelerator with an OPTIVUE or MVision imaging system that has the potential collision problem of the imaging pan
- Apr 3, 2012 · Not classified · Z-1486-2012: SIEMENS has received reports where a dropping down of the 550 TxT" Treatment Table was observed while the table was being moved downwards during operation by means of the hand control.
- 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.
- Nov 9, 2011 · Not classified · Z-0459-2012: Reports of gantry rotation without receiving a movement command caused by an overload within the drive signal power line.
- 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
- May 25, 2011 · Not classified · Z-2789-2011: Potential safety issue of possible data loss for the transfer of the same patients treatment data between the LANTIS OIS and the RTT v2.x software and the RT Therapist version 4.1 system
- Mar 31, 2011 · Not classified · Z-2216-2011: Siemens has become aware of a potential safety issue that may result in mistreatment when customers are configured with the ARTISTE Linac RT Therapist v4.2 in combination with RT Oncologist v.4.2 and 
- Mar 31, 2011 · Not classified · Z-2243-2011: Siemens found a potential safety issue related to patient treatment with table offsets on syngo RT Therapist (RTT) 4.1 and 4.2 which could result in dose being delivered to wrong location.
- Mar 24, 2011 · Not classified · Z-2190-2011: When using the ARTISTE Linac and RT Therapist v4.1 along with an imported cropped reference image, the image maybe processed incorrectly, thus resulting in a mistreatment.
- 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.
- Mar 6, 2009 · Not classified · Z-2000-2011: The product has a software problem; it does not calculate the Creatinine Clearance correctly for patients less than two years old.
- May 15, 2008 · Not classified · Z-2100-2008: Software - Under certain circumstances, the portal image may be overwritten, which may lead to incorrect dosage.
- May 15, 2008 · Not classified · Z-2097-2008: Software - Under certain circumstances, the portal image may be overwritten, which may lead to incorrect dosage.
- May 15, 2008 · Not classified · Z-2098-2008: Software - Under certain circumstances, the portal image may be overwritten, which may lead to incorrect dosage.
- May 15, 2008 · Not classified · Z-2104-2008: Software - Under certain circumstances, the portal image may be overwritten, which may lead to incorrect dosage.
- May 15, 2008 · Not classified · Z-2096-2008: Software - Under certain circumstances, the portal image may be overwritten, which may lead to incorrect dosage.
- May 15, 2008 · Not classified · Z-2095-2008: Software - Under certain circumstances, the portal image may be overwritten, which may lead to incorrect dosage.
- May 15, 2008 · Not classified · Z-2101-2008: Software - Under certain circumstances, the portal image may be overwritten, which may lead to incorrect dosage.
- May 15, 2008 · Not classified · Z-2103-2008: Software - Under certain circumstances, the portal image may be overwritten, which may lead to incorrect dosage.
- May 15, 2008 · Not classified · Z-2102-2008: Software - Under certain circumstances, the portal image may be overwritten, which may lead to incorrect dosage.
- May 15, 2008 · Not classified · Z-2099-2008: Software - Under certain circumstances, the portal image may be overwritten, which may lead to incorrect dosage.
- Jan 11, 2008 · Not classified · Z-1400-2008: Linear accelerator gantry may rotate in an unexpected direction and may cause patient injury on impact.
- Dec 10, 2007 · Not classified · Z-1761-2008: Radiation leak: When used with field sizes of 5cm x 5cm or smaller, product may leak radiation at a distance of 2 cm from the side of the applicator body up to 13%, in excess of IEC standards.
- Dec 10, 2007 · Not classified · Z-1760-2008: Radiation leak: When used with field sizes of 5cm x 5cm or smaller, product may leak radiation at a distance of 2 cm from the side of the applicator body up to 13%, in excess of IEC standards.
- Dec 10, 2007 · Not classified · Z-1762-2008: Radiation leak: When used with field sizes of 5cm x 5cm or smaller, product may leak radiation at a distance of 2 cm from the side of the applicator body up to 13%, in excess of IEC standards.
- Dec 10, 2007 · Not classified · Z-1763-2008: Radiation leak: When used with field sizes of 5cm x 5cm or smaller, product may leak radiation at a distance of 2 cm from the side of the applicator body up to 13%, in excess of IEC standards.
- Nov 6, 2007 · Not classified · Z-0099-2009: Flat panel positioning calibration could be off by as much as 4 mm without the machine discovering detail.
- Nov 6, 2007 · Not classified · Z-0092-2009: Flat panel positioning calibration could be off by as much as 4 mm without the machine discovering detail.
- Nov 6, 2007 · Not classified · Z-0089-2009: Flat panel positioning calibration could be off by as much as 4 mm without the machine discovering detail.
- Nov 6, 2007 · Not classified · Z-0091-2009: Flat panel positioning calibration could be off by as much as 4 mm without the machine discovering detail.
- Nov 6, 2007 · Not classified · Z-0093-2009: Flat panel positioning calibration could be off by as much as 4 mm without the machine discovering detail.
- Nov 6, 2007 · Not classified · Z-0094-2009: Flat panel positioning calibration could be off by as much as 4 mm without the machine discovering detail.
- Nov 6, 2007 · Not classified · Z-0097-2009: Flat panel positioning calibration could be off by as much as 4 mm without the machine discovering detail.
- Nov 6, 2007 · Not classified · Z-0090-2009: Flat panel positioning calibration could be off by as much as 4 mm without the machine discovering detail.
- Nov 6, 2007 · Not classified · Z-0095-2009: Flat panel positioning calibration could be off by as much as 4 mm without the machine discovering detail.
- Nov 6, 2007 · Not classified · Z-0098-2009: Flat panel positioning calibration could be off by as much as 4 mm without the machine discovering detail.
- Nov 6, 2007 · Not classified · Z-0096-2009: Flat panel positioning calibration could be off by as much as 4 mm without the machine discovering detail.

## Indications for use
The intended use of the ONCOR Expression TM linear accelerator system is to deliver x-ray radiation for therapeutic treatment of cancer. The ONCOR Expression includes an Electronic Portal Imaging Device (EPID) that will be marketed as OPTIVUETM 10OOST. The indications for use for the OPTIVUE 1000ST is the acquisition of portal images for the purpose of verification of the treatment field and shielding blocks in relation to patient positioning markers and/or anatomical landmarks in radiotherapy treatment. OPTIVUE 10OOOST will also allow for verification of the exit dose in radiotherapy treatment. The indications for use remain unchanged from the previously cleared OPTIVUE EPID (K031764). Additionally, the ONCOR Expression includes as a standard feature, an 82 leaf multi-leaf collimator that is marketed as OPTIFOCUSTM. The OPTIFOCUS MVLG 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 of the OPTIFOCUS MVLC remains unchanged from the previously cleared OPTIFOCUS MVLC (K031764). The COHERENCETM Workspaces: The COHERENCE Therapist workspace includes a number of syngoTM based software applications who's indication for use include the viewing, processing, filming, and archiving of medical images. The COHERENCE Therapist Workspace also permits patient data management, patient selection/setup, patient positioning verification, treatment delivery/verification, and treatment recording. The Therapist Workspace in this release includes MVisionTM which consists of the Megavoltage Cone Beam imaging method for acquiring 20 projection data that is reconstructed by the Cone Beam reconstruction method into 3D data for use by the Adaptive TargetingTM application for advanced treatment localization and patient positioning. Adaptive Targeting can also use 3D data imported from other devices. The indications for use for the COHERENCE Therapist workspace remains unchanged from the previously cleared COHERENCE Therapist workspace (K031764).

Source page: https://510kreport.com/device/K060226
Methodology: https://510kreport.com/methodology