(64 days)
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 systems are high-dose rate medical linear accelerators optimized for 3D conformal radiation therapy, intensity-modulated radiation therapy (IMRT), modulated arc therapy (mARC) and precision stereotactic radiation therapy for lesions, turnors and conditions anywhere in the head and body where radiation therapy is indicated.
The Control Console is the operations center for the digital linear accelerator. It contains the digital linear accelerator computer, monitor, and keyboard. From the Control Console, the user can program, initiate, monitor, and control treatments.
The syngo® RT Therapist Workspace is a component of the linear accelerator system and is based on the syngo® architecture. The syngo® RT Therapist workspace contains software applications to support patient selection/setup. patient positioning verification, treatment delivery/verification, and treatment recording.
The syngo® RT Oncologist Workspace is an optional accessory to the linear accelerator system and permits localization, contouring, segmentation, image review and approval of treatment plan parameters. In addition, it includes tools and administrative functions to aid in the diagnosis, staging, and prescription of radiation therapy.
The syngo® RT Therapist and the syngo® RT Oncologist Workspaces v4.3.1 MR3, can be interfaced with third party OIS, V&R, TPS, and PACS devices conforming to the DICOM Standard.
The subject device is a modification of the previously cleared ARTISTE Solution with SYS_VC10C, PHASE 2 Update, with syngo RT Therapist & RT Oncologist Workspaces, V4.3.1 MR1 (K142434). The modification consists of an update to the LINAC Control Console Software (v13.1.010) to enhance the safety of the Automatic Movement Protection feature.
Listed below are additional minor software updates:
- IBL: enabling pressure & temperature compensation for imaging beams
- MON 2: adjustments to the secondary dose monitoring system for small total doses to terminate radiation when the selected number of MUs is exceeded by not more than 10% (valid for <= 250 MU)
- Treatment Timer: adjustments to the preset value calculation for the maximum allowed treatment time
There is no new manufacturing of Siemens Medical Linear Accelerators as of October 1, 2012, and therefore no forward production of the subject device. The subject device will only be offered as customer support to the installed base and as optional interface upgrades to support third party Oncology Information Systems (OIS).
The provided text describes a 510(k) premarket notification for a software update to Siemens linear accelerator systems. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than undergoing a de novo clinical trial to establish new safety and effectiveness claims.
Based on the provided document, the device in question is a software update (ccNode Software v13.1.010 Update) for existing Siemens linear accelerators and related workspaces. The key purpose of this update is to enhance the safety of the Automatic Movement Protection feature and includes other minor software adjustments.
Therefore, the typical structure for reporting acceptance criteria and study results for AI/ML-based diagnostic or prognostic devices (which would involve detailed performance metrics like sensitivity, specificity, AUC, human reader studies, etc.) does not apply directly to this submission. This document pertains to a software update for a therapeutic device's control system, where the focus is on maintaining or improving safety and performance compared to the previously cleared version, primarily through non-clinical verification and validation.
Here's an analysis based on the provided text, addressing the points where information is available or noting when it's not applicable in this context:
1. A table of acceptance criteria and the reported device performance:
This document does not present quantitative acceptance criteria or performance metrics in a table format as would be seen for an AI/ML diagnostic device (e.g., target specificity of X%, achieved specificity of Y%). Instead, the "acceptance criteria" are implied by the successful completion of verification and validation activities, demonstrating that the software performs as intended and maintains the safety and effectiveness profile of the predicate device.
The reported "performance" is that the device "performs as intended and is thus substantially equivalent to the predicate device" (Page 6, Section 9) and that the modified features "bear an equivalent safety and performance profile" (Page 6, Section 8, and Page 7, Section 11).
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated in terms of patient data or case numbers. Software verification and validation typically involve testing against various functional requirements, simulated scenarios, and potentially specific hardware configurations, rather than a "test set" of patient cases in the way an AI diagnostic device would.
- Data Provenance: Not applicable in the context of patient data for this software update. The testing relates to the software's functionality and safety within the linear accelerator system.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. Ground truth, in the sense of expert consensus on medical images or diagnoses, is not established for this type of software update. The "truth" here is whether the software functions correctly and safely according to its specifications and regulatory standards.
- Qualifications of Experts: Not applicable for establishing "ground truth" in this context. Rather, software engineers, quality assurance personnel, and regulatory affairs specialists would be involved in the verification and validation processes.
4. Adjudication method for the test set:
- Adjudication Method: Not applicable. This concept applies to resolving discrepancies in expert interpretations of medical data, which is not the type of testing performed for this software update.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- MRMC Study: No. The document explicitly states: "No clinical tests were conducted to support the claim of substantial equivalence between the subject and predicate device." (Page 7, Section 9). This is a software update for a therapeutic device's control system, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: The "performance" of this software is its ability to control the linear accelerator systems safely and effectively. The verification and validation activities assess this, but it's not measured in terms of diagnostic accuracy metrics. The software operates within a human-controlled system (the Control Console, syngo RT Therapist/Oncologist Workspaces), so its performance is inherently tied to that interaction.
7. The type of ground truth used:
- Type of Ground Truth: For this software, "ground truth" is primarily based on software specifications, functional requirements, risk analysis outcomes, and compliance with recognized industry standards (e.g., IEC 62304 for software, IEC 60601 series for electrical medical equipment, ISO 14971 for risk management). The software is evaluated against these predefined correct behaviors and safety requirements, not against biological or clinical outcomes in patients.
8. The sample size for the training set:
- Training Set Sample Size: Not applicable. This is a software update for existing functionality and safety enhancements, not a machine learning model developed with a "training set" of data.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable, as this is not an AI/ML model that requires a training set and associated ground truth labels.
In summary of the provided document:
The submission for K182050 is for a software update to medical linear accelerator control systems. The demonstration of substantial equivalence relies heavily on non-clinical performance testing, specifically software verification and validation (V&V) conducted in accordance with FDA guidance documents and relevant international standards (e.g., IEC 62304, ISO 14971). The "study" proving the device meets its criteria is this rigorous V&V process, which confirms the software performs as intended, enhances safety, and maintains an equivalent safety and performance profile to the predicate device without requiring new clinical outcome data or diagnostic performance studies.
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October 3, 2018
Siemens Medical Solutions USA, Inc. Martin Rajchel Regulatory Affairs Specialist 40 Liberty Boulevard, Mail Code 65-1A MALVERN, PA 19355
Re: K182050
Trade/Device Name: Linear Accelerator Control Console Software v13.1.010 Update for Siemens PRIMUS™, ONCOR™, ARTISTE™, and syngo® RT Therapist & RT Oncologist Workspaces, v4.3.1 MR3 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE Dated: July 30, 2018 Received: July 31, 2018
Dear Martin Rajchel:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara For
Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K182050
Device Name
ccNode Software v13.1.010 Update for Siemens PRIMUS™, ONCOR™, ARTISTE™, and syngo® RT Therapist & RT Oncologist Workspaces, v4.3.1 MR3
Indications for Use (Describe)
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 systems are high-dose rate medical linear accelerators optimized for 3D conformal radiation therapy, intensity-modulated radiation therapy (IMRT), modulated arc therapy (mARC) and precision stereotactic radiation therapy for lesions, turnors and conditions anywhere in the head and body where radiation therapy is indicated.
The Control Console is the operations center for the digital linear accelerator. It contains the digital linear accelerator computer, monitor, and keyboard. From the Control Console, the user can program, initiate, monitor, and control treatments.
The syngo® RT Therapist Workspace is a component of the linear accelerator system and is based on the syngo® architecture. The syngo® RT Therapist workspace contains software applications to support patient selection/setup. patient positioning verification, treatment delivery/verification, and treatment recording.
The syngo® RT Oncologist Workspace is an optional accessory to the linear accelerator system and permits localization, contouring, segmentation, image review and approval of treatment plan parameters. In addition, it includes tools and administrative functions to aid in the diagnosis, staging, and prescription of radiation therapy.
The syngo® RT Therapist and the syngo® RT Oncologist Workspaces v4.3.1 MR3, can be interfaced with third party OIS, V&R, TPS, and PACS devices conforming to the DICOM Standard.
| Type of Use (Select one or both, as applicable) | |||
|---|---|---|---|
| XPrescription Use (Part 21 CFR 801 Subpart D) | X | Prescription Use (Part 21 CFR 801 Subpart D) | |
| X | Prescription Use (Part 21 CFR 801 Subpart D) | ||
| Over-The-Counter Use (21 CFR 801 Subpart C) | Over-The-Counter Use (21 CFR 801 Subpart C) | ||
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
ccNode Software v13.1.010 Update for Siemens PRIMUS™, ONCOR™, ARTISTE™, and syngo® RT Therapist & RT Oncologist Workspaces, v4.3.1 MR3
Company: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355, USA Establishment Registration Number: 2240869
Date Prepared July 30, 2018
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR § 807.92.
1. General Information
Importer/Distributor:
Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355, USA Establishment Registration Number: 2240869
Manufacturing Sites:
Siemens AG, Medical Solutions Radiation Oncology Doris-Ruppenstein-Str. 4 Erlangen, Germany, 91052 Registration Number: 3006894636
2. Contact Information
Martin Rajchel Requlatory Affairs Specialist Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355, USA Phone: (610) 448-6545 Fax: (610) 640-4481 Email: martin.rajchel@siemens-healthineers.com Rolf Meisel Requlatory Manager Siemens Healthcare GmbH Roentgenstr. 19-21 Kemnath, Bavaria, 95478. Germany Phone: +49 (9642) 18-7424 Fax: +49 (9642) 18-1424 Email: rolf.meisel@siemens-healthineers.com
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3. Device Name and Classification
| Trade name | ccNode Software v13.1.010 Update for Siemens PRIMUS™,ONCOR™, ARTISTE™, and syngo® RT Therapist & RTOncologist Workspaces, v4.3.1_MR3 |
|---|---|
| Classification Name | Medical charged-particle radiation therapy system |
| Classification Panel: | Radiology |
| Regulation Number: | 21 CFR § 892.5050 |
| Device Class: | II |
| Product Code: | IYE |
4. Legally Marketed Predicate Device
| Trade Name | ARTISTE Solution with SYS_VC10C, PHASE 2 Update, withsyngo RT Therapist & RT Oncologist Workspaces,V4.3.1_MR1 |
|---|---|
| 510(k) Number | K142434, Cleared November 21, 2014 |
| Classification Name: | Medical charged-particle radiation therapy system |
| Classification Panel: | Radiology |
| CFR Code: | 21 CFR § 892.5050 |
| Classification: | Class II |
| Product Code: | Primary: IYE |
5. Device Description
The subject device is a modification of the previously cleared ARTISTE Solution with SYS_VC10C, PHASE 2 Update, with syngo RT Therapist & RT Oncologist Workspaces, V4.3.1 MR1 (K142434). The modification consists of an update to the LINAC Control Console Software (v13.1.010) to enhance the safety of the Automatic Movement Protection feature.
Listed below are additional minor software updates:
- IBL: enabling pressure & temperature compensation for imaging beams ●
- MON 2: adjustments to the secondary dose monitoring system for small . total doses to terminate radiation when the selected number of MUs is exceeded by not more than 10% (valid for <= 250 MU)
- Treatment Timer: adjustments to the preset value calculation for the ● maximum allowed treatment time
There is no new manufacturing of Siemens Medical Linear Accelerators as of October 1, 2012, and therefore no forward production of the subject device. The subject device will only be offered as customer support to the installed base and as optional interface upgrades to support third party Oncology Information Systems (OIS).
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SIEMEI
6. Indication for Use
The indications for use for the subject device is the same as the predicate device:
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 systems are high-dose and high-dose rate medical linear accelerators optimized for 3D conformal radiation therapy, intensity-modulated radiation therapy (IMRT), modulated arc therapy (mARC) and precision stereotactic radiation therapy for lesions, tumors and conditions anywhere in the head and body where radiation therapy is indicated.
The Control Console is the operations center for the digital linear accelerator. It contains the digital linear accelerator computer, monitor, and keyboard. From the Control Console, the user can program, initiate, monitor, and control treatments.
The syngo® RT Therapist Workspace is a component of the linear accelerator system and is based on the syngo architecture. The syngo® RT Therapist workspace contains software applications to support patient selection/setup, patient positioning verification, treatment delivery/verification, and treatment recording.
The syngo® RT Oncologist Workspace is an optional accessory to the linear accelerator system and permits localization, contouring, seqmentation, image review and review and approval of treatment plan parameters. In addition, it includes tools and administrative functions to aid in the diagnosis, staging, and prescription of radiation therapy.
The syngo® RT Therapist and the syngo® RT Oncologist Workspaces v4.3.1_MR3, can be interfaced with third party OIS, V&R, TPS, and PACS devices conforming to the DICOM Standard.
7. Substantial Equivalence
ccNode Software v13.1.010 Update for Siemens PRIMUS™, ONCOR™, ARTISTE™, and syngo® RT Therapist & RT Oncologist Workspaces, v4.3.1 MR3 is substantially equivalent to the following predicate device:
| Predicate Device | FDA ClearanceNumber | FDAClearanceDate | ProductCode |
|---|---|---|---|
| ARTISTE Solution withSYS_VC10C, PHASE 2Update, with syngo RTTherapist & RT OncologistWorkspaces, V4.3.1_MR1 | K142434 | November21, 2014 | IYE |
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The comparison of technological characteristics, non-clinical performance data, and software verification and validation data demonstrates that the subject device is as safe and effective when compared to the predicate device currently marketed for the same intended use.
8. Summary of Technological Characteristics of the Subject Device as Compared with the Predicate Device
The subject device ccNode Software v13.1.010 Update for Siemens PRIMUS™. ONCOR™, ARTISTE™, and syngo® RT Therapist & RT Oncologist Workspaces, v4.3.1 MR3, is substantially equivalent to the predicate device, ARTISTE Solution with SYS_VC10C, PHASE 2 Update, with syngo RT Therapist & RT Oncologist Workspaces, V4.3.1_MR1, with regard to the operational environment, programming language, operating system, and performance.
The subject device conforms to the IEC 62304, Edition 1.0, 2006-05, standard for software medical devices and other relevant IEC and NEMA standards.
While the software modifications for the subject device present some differences in technological characteristics compared to the predicate device, these differences have been tested and the conclusions from the non-clinical data suggests that the features bear an equivalent safety and performance profile to that of the predicate device.
9. Nonclinical Performance Testing
The following performance testing was conducted on the subject device:
- Software verification and validation testing was completed in accordance with the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", dated May 11, 2005.
The results from each set of tests demonstrate that the device performs as intended and is thus substantially equivalent to the predicate device to which it has been compared.
ccNode Software v13.1.010 Update for Siemens PRIMUS™, ONCOR™, ARTISTE™, and syngo RT Therapist & RT Oncologist Workspaces, v4.3.1 MR3 conforms to the following standards for Radiological Oncology devices and their major components:
| Title of Standard | Version | PublicationDate |
|---|---|---|
| IEC 61217:2011Radiotherapy equipment - Coordinates, movements, and scales | Ed. 2.0 | 8-Sep-09 |
| IEC 62274:2005-05Medical electrical equipment - safety of radiotherapy record and verifysystems | Ed. 1.0 | 9-Sep-08 |
| IEC 60976:2007-10:Medical electrical equipment - Medical electron accelerators -Functional performance characteristics | Ed. 2.0 | 18-Mar-09 |
| ISO 14971:2007: Medical devices - Application of risk management tomedical devices | Ed. 2.0 | 27-Jun-16 |
| IEC 62304:2006: Medical device software - Software life cycleprocesses | Ed. 1.0 | 9-May-06 |
Siemens Traditional 510(k) Premarket Notification
July 30, 2018
ccNode Software v13.1.010 Update for Siemens PRIMUS™, ONCOR™, ARTISTE™, and syngo RT Therapist & RT Oncologist Workspaces, v4.3.1_MR3
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| IEC 60601-1:1988 + A1 +A2 /EN 60601-1:1990 + A1:1993 +A2:1995/UL 60601-1:2003: Medical Electrical Equipment, GeneralRequirements for Safety | Ed. 2.0 | 7-Mar-95 |
|---|---|---|
| IEC 60601-1-4:2000, Consolidated Ed. 1.1, Medical ElectricalEquipment - Part 1-4: General Requirements for Collateral Standard:Programmable Electrical Medical Systems. | Ed. 1.1 | 7-Apr-00 |
| IEC 60601-2-1:1998 +A 1 2002:Medical electrical equipment - Part 2-1: Particular requirements for the safety of electron accelerators in therange 1 MeV to 50 MeV | Ed. 2.0 | 30-Jun-98 |
| IEC 62366:2007: Medical Devices - Application of usability engineeringto medical devices. & IEC 60601-1-6 Collateral Standard usability | Ed. 1.0 | 18-Oct-07 |
| IEC 60601-1-1:2000:Medical electrical equipment - Part 1-1:Generalrequirements for safety-Collateral standard: Safety requirements formedical electrical systems. (General). | Ed. 2.0 | 14-Dec-00 |
| IEC 60601-1-2:2007: Medical electrical equipment - Part 1 - 2: Generalrequirements for basic safety and essential performance - Collateralstandard: Electromagnetic compatibility -Requirements and tests | Ed. 3.0 | 30-Mar-07 |
No clinical tests were conducted to support the claim of substantial equivalence between the subject and predicate device.
10. General Safety and Effectiveness Concerns
The device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of the device.
Risk management is ensured via compliance with ISO 14971:2007 to identify and provide mitigation of potential hazards in a risk analysis early in the design phase and continuously throughout the development of the product. These risks are controlled via measures realized in hardware and software development, testing, and product labeling. To minimize risks, Siemens adheres to recognized and established industry practices and standards, such as the IEC 60601-1 series, to minimize electrical and mechanical risk. Furthermore, the device is intended for healthcare professionals familiar with and responsible for using linear accelerator systems to deliver x-ray photon and electron radiation for the therapeutic treatment of cancer.
11.Conclusion as to Substantial Equivalence
While the software modifications for the subject device constitute a difference in technological charcteristics compared to the predicate device, the conclusions from all verification and validation data suggest the features bear an equivalent safety and performance profile as that of the predicate device. The software modifications provide safety enhancements and do not impact the intended use compared to the predicate device.
Siemens concludes that the subject device, ccNode Software v13.1.010 Update for Siemens PRIMUS™, ONCOR™, ARTISTE™, and syngo® RT Therapist & RT Oncologist Workspaces, v4.3.1_MR3, is substantially equivalent to the predicate device, ARTISTE Solution with SYS VC10C, PHASE 2 Update, with syngo RT Therapist & RT Oncologist Workspaces, V4.3.1 MR1 (K142434)
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.