TrueBeam, TrueBeam STx, Edge, VitalBeam
Device Facts
| Record ID | K231317 |
|---|---|
| Device Name | TrueBeam, TrueBeam STx, Edge, VitalBeam |
| Applicant | Varian Medical Systems, Inc. |
| Product Code | IYE · Radiology |
| Decision Date | Sep 12, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.5050 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Pediatric |
Indications for Use
TrueBeam-TrueBeam STx-Edge: The TrueBeam ™ radiotherapy delivery system is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated. VitalBeam: The VitalBeam system is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
Device Story
Medical linear accelerator delivering therapeutic radiation (photon, electron, kV X-ray) to patients; installed in radiation-shielded vault with control console outside. System transforms physician-prescribed treatment plans into precise radiation delivery via gantry, collimator, and couch movements. Used by clinicians for stereotactic radiosurgery and radiotherapy. New features include extended field-of-view CBCT reconstruction, template-based fiducial detection for Auto Beam Hold, 1.5 RPM gantry speed for imaging, and metal artifact reduction. Output includes radiation dose delivery and diagnostic images (CBCT, fluoroscopy, radiographs). Healthcare providers use output to verify patient positioning and treatment accuracy; enables precise tumor targeting while sparing healthy tissue.
Clinical Evidence
No clinical or animal testing submitted. Substantial equivalence established via bench testing, software verification/validation, and conformance to recognized consensus standards (IEC 60601 series, ISO 10993-1, ISO 14971).
Technological Characteristics
Medical linear accelerator; photon/electron/kV X-ray energy sources. Features: 120-leaf or HD120 MLC, 43x43 kV imager, robotic couch (4DoF/6DoF). Connectivity: DICOM RT/3.0, ADI v2.0/v3.0. Software: Windows 10 platform. Standards: IEC 60601-1, IEC 60601-2-1, IEC 62304, ISO 10993-1, ISO 14971.
Indications for Use
Indicated for adults and pediatric patients requiring stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body, including brain, spine, head/neck, thoracic, gynecologic, gastrointestinal, genitourinary, breast, sarcomas, lymphoid, skin, benign diseases, and metastasis. Medically refractory essential tremor indicated for adults only.
Regulatory Classification
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.
Predicate Devices
- TrueBeam /TrueBeam STx /Edge /VitalBeam (K213977)
Submission Summary (Full Text)
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September 12, 2023
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Varian Medical Systems, Inc. % Peter J. Coronado Sr. Director, Regulatory Affairs 3100 Hansen Way. PALO ALTO CA 94304
Re: K231317
Trade/Device Name: TrueBeam, TrueBeam STx, Edge, VitalBeam Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-Particle Radiation Therapy System Regulatory Class: Class II Product Code: IYE Dated: August 11, 2023 Received: August 14, 2023
Dear Peter J. Coronado:
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 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
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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Xin He A for
Lora D. Weidner, Ph.D. Assistant Director Radiation Therapy Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K231317
Device Name
TrueBeam, TrueBeam STx and Edge Radiotherapy Delivery System; VitalBeam
#### Indications for Use (Describe) TrueBeam-TrueBeam STx-Edge:
The TrueBeam™, TrueBeam STx and Edge™ Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere radiation therapy is indicated for adults and pediatric patients. The TrueBeam, TrueBeam STx, and Edge Systems may be used in the delivery of radiation for treatment that includes: brain and spine tumors (such as glioma, meningioma, pitutary tumors, spinal cord tumors, hemangioblastoma, orbital tumors, ocular tumors, and skull based tumors), head and neck tumors (such as unknown primary of the head and neck, oral cavity, hypopharynx, nasopharynx, sinonasal, salivary gland, and thyroid cancer), thoracic tumors (such as lung cancer, thymic tumors, and mesothelioma), gynecologic tumors (such as ovarian, cervical, endometrial, vulvar, and vaginal), gastrointestinal tumors (such as gastric, pancreatic, hepatobiliary, colon, rectal, and anal carcinoma), genitourinary tumors (such as prostate, bladder, testicular, and kidney), breast tumors, sarcomas, lymphoid tumors (such as Hodgkin's and non-Hodgkin's lymphoma), skin cancers (such as squamous cell, and melanoma), benign diseases (such as schwannoma, arteriovenous malformation, cavernous malformation, trigeminal neuralgia, chordoma, gand hemangiomas), metastasis (including all parts of the body such as brain, bone, liver, lung, kidney, and skin) and pediatric tumors (such as glioma, ependymoma, pituitary tumors, hemangioblastoma, meningioma, metastasis, meduloblastoma, nasopharyngeal tumors, arteriovenous malformation, and skull base tumors), and medically refractory essential tremor (indicated for adults only).
#### VitalBeam:
VitalBeam: VitalBeam® is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediative patients. VitalBeam may be used in the delivery of radiation for treatment that includes: brain and spine tumors (such as glioma, meningioma, craniopharyngiona, pituitary tumors, spinal cord tumors, hemangioblastoma, orbital tumors, optic nerve tumors, and skull based tumors), head and neck tumors (such as unknown primary of the head and neck, oral cavity, hypopharynx, larynx, oropharynx, sinonasal, salivary gland, and thyroid cancer), thoracic tumors (such as lung cancer, esophageal cancer, thymic tumors, and mesothelioma), gynecologic tumors (such as ovarian, cervical, endometrial, vulvar, and vaginal), gastrointestinal tumors (such as gastric, pancreatic, hepatobiliary, colon, rectal, and anal carcinoma), genitourinary tumors (such as prostate, bladder, testicular, and kidney), breast tumors, sarcomas, lymphoid tumors (such as Hodgkin's and non-Hodgkin's lymphoma), skin cancers (such as squamous cell, and melanoma), benign diseases (such as schwannoma, arteriovenous malformation, cavernous malformation, trigeminal neuralgia, chordoma, glomus tumors, and hemangiomas), metastasis (including all parts of the body such as brain, bone, liver, lung, kidney, and skin) and pediatric tumors (such as glioma, pituitary tumors, hemangioblastoma, craniopharyngioma, meningioma, metastasis, medulloblastoma, nasopharyngeal tumors, arteriovenous malformation, cavernous malformation, and skull base tumors).
Type of Use (Select one or both, as applicable)
> Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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varian
K231317
Varian Medical Systems 3100 Hansen Way Palo Alto, CA 94304
The following information is provided as required by 21 CFR 807.92.
| SUBMITTER | |
|----------------------------------|----------------------------------------------------|
| Name and Address: | Varian Medical Systems |
| | 3100 Hansen Way, m/s E110 |
| | Palo Alto, CA 94304 |
| Contact Person: | Peter J. Coronado |
| | Sr. Director, Regulatory Affairs |
| | Phone: 650-424-6320 Fax: 650-646-9200 |
| | submissions.support@varian.com |
| | |
| Date Prepared: | 05 May 2023 |
| | |
| DEVICE | |
| Subject Device Name: | TrueBeam™ /TrueBeam STx™/Edge™/VitalBeam |
| Common/Usual Name: | Linear accelerator radiation therapy system |
| Product Code and Classification: | Medical charged-particle radiation therapy system |
| | IYE 21 CFR 892.5050 Class II |
| PREDICATE DEVICE | |
| Predicate Device Name: | TrueBeam™ /TrueBeam STx™/Edge™/VitalBeam (K213977) |
| Reference Device(s): | No reference devices were used in this submission. |
#### DEVICE DESCRIPTION
The TrueBeam and VitalBeam Radiotherapy System is a medical linear accelerator that delivered therapeutic radiation to patient in accordance with the physician's prescription.
The system consists of two major components – a photon, electron and diagnostic kV X-ray radiation beam producing component that is installed in a radiation-shielded vault and a control console area located outside the treatment room.
#### INTENDED USE
TrueBeam-TrueBeam STx-Edge: The TrueBeam ™ radiotherapy delivery system is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
VitalBeam: The VitalBeam system is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
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Image /page/5/Picture/0 description: The image shows the logo for Varian, a Siemens Healthineers Company. The word "Varian" is written in a bold, sans-serif font. Below the word "Varian" is the text "A Siemens Healthineers Company" in a smaller, sans-serif font. The logo is black and white.
# INDICATIONS FOR USE
#### TrueBeam-TrueBeam STx-Edge:
The TrueBeam™, TrueBeam STx and Edge™ Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.
The TrueBeam, TrueBeam STx, and Edge Systems may be used in the delivery of radiation for treatment that includes: brain and spine tumors (such as glioma, meningioma, craniopharyngioma, pituitary tumors, spinal cord tumors, hemangioblastoma, orbital tumors, ocular tumors, optic nerve tumors, and skull based tumors), head and neck tumors (such as unknown primary of the head and neck, oral cavity, hypopharynx, larynx, oropharynx, nasopharynx, sinonasal, salivary gland, and thyroid cancer), thoracic tumors (such as lung cancer, esophageal cancer, thymic tumors, and mesothelioma), gynecologic tumors (such as ovarian, cervical, endometrial, vulvar, and vaginal), gastrointestinal tumors (such as gastric, pancreatic, hepatobiliary, colon, rectal, and anal carcinoma), genitourinary tumors (such as prostate, bladder, testicular, and kidney), breast tumors, sarcomas, lymphoid tumors (such as Hodqkin's and non-Hodqkin's lymphoma), skin cancers (such as squamous cell, and melanoma), benign diseases (such as schwannoma, arteriovenous malformation, cavernous malformation, trigeminal neuralgia, chordoma, glomus tumors, and hemangiomas), metastasis (including all parts of the body such as brain, bone, liver, lung, kidney, and skin) and pediatric tumors (such as qlioma, ependymoma, pituitary tumors, hemanqioblastoma, craniopharynqioma, metastasis, medulloblastoma, nasopharynqeal tumors, arteriovenous malformation, cavernous malformation, and skull base tumors), and medically refractory essential tremor (indicated for adults only).
#### VitalBeam:
VitalBeam® is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.
VitalBeam may be used in the delivery of radiation for treatment that includes: brain and spine tumors (such as glioma, meningioma, craniopharyngioma, pituitary tumors, spinal cord tumors, hemangioblastoma, orbital tumors, ocular tumors, optic nerve tumors, and skull based tumors), head and neck tumors (such as unknown primary of the head and neck, oral cavity, hypopharynx, larynx, oropharynx, nasopharynx, sinonasal, salivary gland, and thyroid cancer), thoracic tumors (such as lung cancer, esophageal cancer, thymic tumors, and mesothelioma), gynecologic tumors (such as ovarian, cervical, endometrial, vulvar, and vaginal), gastrointestinal tumors (such as gastric, pancreatic, hepatobiliary, colon, rectal, and anal carcinoma), genitourinary tumors (such as prostate, bladder, testicular, and kidney), breast tumors, sarcomas, lymphoid tumors (such as Hodgkin's and non-Hodgkin's lymphoma), skin cancers (such as squamous cell, basal cell, and melanoma), benign diseases (such as schwannoma, arteriovenous malformation, cavernous malformation, trigeminal neuralqia, chordoma, glomus tumors, and hemangiomas), metastasis (including all parts of the body such as brain, bone, liver, lung, kidney, and skin) and pediatric tumors (such as glioma, ependymoma, pituitary tumors,
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Image /page/6/Picture/0 description: The image shows the logo for Varian, a Siemens Healthineers Company. The word "varian" is written in a bold, sans-serif font. Below the word "varian" is the text "A Siemens Healthineers Company" in a smaller font. The logo is simple and modern.
hemanqioblastoma, craniopharyngioma, metastasis, medulloblastoma, nasopharyngeal tumors, arteriovenous malformation, cavernous malformation, and skull base tumors).
#### SIGNIFICANT DIFFERENCES
The significant changes in the subject device compared to the predicate device are as follows:
- . Extended field of view CBCT reconstruction
- . Templated-based fiducial detection algorithm for Auto Beam Hold
- . 1.5 RPM gantry speed for imaging
- Metal artifact reduction .
# SUMMARY OF TECHNOLOGICAL CHARACTERISTICS
Both subject device and the predicate device contain the same technological characteristics and functional scientific technology to deliver radiation therapy and stereotactic radiosurgery by authorized medical practitioners. A subset of technological characteristics and features of the current device is different to the predicate. These differences are all enhancements of the Intended Use and indications for use are unchanged. There are no changes in the principle of operation of the device. The biocompatibility of patient-contacting components remains the same as the predicate device. The results of the verification, validation and safety standards testing demonstrates that there are no changes to the safety profile of the device.
The feature comparison chart below shows the difference between predicate and subject device. The features in blue text in table below are new to the subject device.
| Feature | Predicate Device<br>TrueBeam and<br>VitalBeam v3.0<br>(K213977) | Subject Device<br>TrueBeam-TrueBeam<br>STx-Edge and<br>VitalBeam v4.0 |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|-----------------------------------------------------------------------|
| Intended Use:<br>The TrueBeam® system is intended to provide stereotactic<br>radiosurgery and precision radiotherapy for lesions, tumors, and<br>conditions anywhere in the body where radiation treatment is<br>indicated.<br>The VitalBeam system is intended to provide stereotactic<br>radiosurgery and precision radiotherapy for lesions, tumors, andindicated. | Yes | Yes |
| Software Operating System | Windows 10 | Windows 10 |
| Treatment Techniques | | |
| Basic integral treatment techniques include static photon,<br>static aperture photon arc, and dynamic conformal arc. Additional treatment techniques include static electron<br>and electron arc, IMRT/IMRS, RapidArc and VMAT, Total<br>Body treatments (photon and electron). All photon treatment delivery techniques can be delivered<br>under respiratory gating conditions. Fully automated treatment delivery | Yes | Yes |
| Dynamic collimator for IMRT and VMAT | No | Yes |
| Mixed static and dynamic gantry-modulated fields | No | Yes |
| Unicode | Yes | Yes |
| Jaw tracking, Trajectory logs, RDSR & Smart connect | Yes | Yes |
| Automated Dynamic Beam (aka ADB /4Pi / Hyperarc) | Yes | Yes |
| Enlarged Bounding Box (w/in HyperArcTM) | Yes | Yes |
| Treatment Energy used 6-16 MV (BJR-17), 6-22 MeV | Yes | Yes |
| Treatment Energy used 4-25MV (BJR 17), 6-22 MeV | Yes | Yes |
| 6x FFF (High Intensity Mode) | Yes | Yes |
| 10x FFF (High Intensity Mode) | Yes | Yes |
| Varied Dose rate throughout arc travel -<br>Dose rate RT: Up to 600 MU/min<br>High dose rate: Up to 2400 MU/min | Yes | Yes |
| Varied gantry rotation speed throughout arc travel | Yes | Yes |
| Arc treatment Control points between two and 500; segments<br>allowed with zero dose; allowed respiratory gating | Yes | Yes |
| Isocenter ≤1.5 mm for all three rotational axes | Yes | Yes |
| Single Isocenter Multiplan | Yes | Yes |
| LaserGuard II Gantry Collision Detection System | Yes | Yes |
| Couch | | |
| Treatment Couch Motions | | |
| • Small, corrective motions and large planned or targeted<br>motions for couch longitudinal, lateral, vertical &<br>rotational axes (4DoF).<br>• Dynamic motion axes now include gantry, collimator<br>(jaws, MLC, collimator rotation), couch translation and<br>rotation for patient set up and treatment delivery.<br>• Local (in treatment room) couch motion control for<br>manual positioning and automated positioning to plan<br>values.<br>• Tx Plans pre-treatment QA (incl. exceeding pre-defined<br>dose limits)<br>• Delta Couch automated patient alignment shifts (Delta<br>Couch Shift). | Yes | Yes |
| • (Varian Treatment Couch) - Linear Encoder | | |
| Qfix kVue One Couch Top: s/w support only + MPC support | Yes | Yes |
| Perfect Pitch – automated corrective motion for pitch and roll<br>axes (6 degrees of freedom) | Yes | Yes |
| Treatment application recognizes common isocenter within and<br>across plans then applies couch corrections to the common<br>isocenter. | Yes | Yes |
| Integrated Treatment and Imaging Console | | |
| External beam: X-ray & ELECTRON plus PHOTON beam for<br>SRS/SRT delivery | Yes | Yes |
| Electron Energies: 7MeV & 11MeV | Yes | Yes |
| Coplanar, Non-coplanar, Arc fields | Yes | Yes |
| Beam shaping f(x): Dynamic wedges, Asymmetric collimators | Yes | Yes |
| Conical Collimator Verification (Varian ICVI) | Yes | Yes |
| Recognized patient-specific accessories: Electron Beam<br>Collimators, Poured Blocks, Compensators, Physical wedges | Yes | Yes |
| Patient ID (bar code label) verification & Custom accessory<br>verification (VVS compatibility)<br>• Patient selection from queue provided by the schedule<br>• Selected patient plan retrieval from info system | Yes | Yes |
| VVS - CV (Varian Verification System, conical Cone Verification) compatibility | Yes | Yes |
| Set up verification & beam prevention if setup does not match Tx plan | Yes | Yes |
| Manual bolus verification | Yes | Yes |
| Override treatment parameters based on user rights and permit current session delivery only | Yes | Yes |
| HET console electronically sends Plan setup data to the HET system supervisor | Yes | Yes |
| Access to MLC shape editing | Yes | Yes |
| Graphical display/editing of field parameters | Yes | Yes |
| Auto sequencing of fields for the selected patient | Yes | Yes |
| • Record treatment delivery results<br>• Send History to InfoSys archive in patient record | Yes | Yes |
| Interfaces:<br>• DICOM RT/3.0 data and image import/export capability;<br>• ADI v2.0 and v3.0 | Yes | Yes |
| ADI 3.0 (6DOF wit Brainlab Interoperability) | Yes | Yes |
| Motion Management Interface | Yes | Yes |
| Multi-leaf Collimator | | |
| 120-Leaf MLC | | |
| Maximum field sizes for 120 MLC:<br>Static field size: 40cm x 40cm.<br>Static aperture field size: 30cm x 40cm<br>IMRT field size: 34 cm x 40 cm | Yes | Yes |
| HD120 MLC | | |
| Maximum field sizes for HD120 MLC:<br>Static field size (MLC retracted): 40cm x 40 cm<br>Static aperture field size: 30cm x 22cm<br>IMRT field size: 34 cm x 22 cm | Yes | Yes |
| Imaging Techniques | | |
| MV Photon Imager Component | Yes | Yes |
| Reference Image Feature (Structure, Field Edges, Digital graticule) | Yes | Yes |
| Portal Image Matching: (Matching Common Features, Match<br>Field Edges Plot, Matched Structures and Field Edges, Related<br>Images, Double Exposure, ROI, couch shift values, respiratory-<br>gated image acquisition, marker matching and portal dosimetry image acquisition.) | Yes | Yes |
| Low X imaging energy for high contrast portal imaging | Yes | Yes |
| kV Photon Imager Component | Yes | Yes |
| Integrated Component: MV Imager w/photon imaging:<br>43 x 43 imager | Yes | Yes |
| Larger kV imager 43x43 | No | Yes |
| Metal artifact reduction | No | Yes |
| Extended FoV CBCT reconstruction | No | Yes |
| Templated-based fiducial detection algorithm for Auto Beam Hold | No | Yes |
| Proximity detection:<br>Touch guards on kV source, kV detector, positioning units with addition of supplemental capacitive collision detection system (kV CCDS) on kV source | Yes | Yes |
| Type of digital image produced: | | |
| | | |
| • Digital radiographs, fluoroscopic image frames, cone-<br>beam CT image projections, respiratory-gated<br>radiographs, respiration-synchronized fluoroscopic image<br>frames | Yes | Yes |
| • Offline 4D CBCT image projections | Yes | Yes |
| • Offline Multi-scan CBCT images | Yes | Yes |
| • 2D-3D Match | Yes | Yes |
| • Gated CBCT | | |
| • Online 4D CBCT and Extended CBCT<br>• Short Arc СВСТ | Yes | Yes |
| • Iterative CBCT (iCBCT)<br>• Automatic Exposure Control (AEC) | Yes | Yes |
| • Iterative CBCT (iCBCT - includes pelvis large and image<br>gently) | Yes | Yes |
| • iCBCT improvements (Improvement to the iCBCT<br>algorithm, for when the patient's outer contour is<br>changing during a CT scan.) | Yes | Yes |
| • CBCT Mode editor | No | Yes |
| • Marker-less 4D CBCT binning | Yes | Yes |
| Movie Encoding Service | Yes | Yes |
| Basis of image comparison:<br>Soft tissue, bony anatomy, fiducial markers, digital representation<br>of treatment aperture | Yes | Yes |
| Image comparison techniques: 2D-2D and 3D-3D image<br>matching under fully automatic conditions using mutual<br>information, or semi-automatic matching conditions with use of<br>both automated image and manual matching, or fully manual<br>matching conditions | Yes | Yes |
| Image comparison with: Soft tissue, bony anatomy, fiducial<br>markers, digital representation of treatment aperture | | |
| Auto Beam hold Improvements | Yes | Yes |
| Marking Pixel Detection…
