CT Rembra RT; CT Areta RT; CT Rembra

{0} FDA U.S. FOOD & DRUG ADMINISTRATION March 23, 2026 Philips Healthcare (Suzhou) Co., Ltd. % Tiffany Zhang Regulatory Affairs Manager No. 258, ZhongYuan Road, Suzhou Industrial Park, Suzhou, Jiangsu Province, 215024 CHINA Re: K252992 Trade/Device Name: CT Rembra RT; CT Areta RT; CT Rembra Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: February 17, 2026 Received: February 17, 2026 Dear Tiffany Zhang: 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 (the 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 available 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. {1} K252992 - Tiffany Zhang Page 2 Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory- {2} K252992 - Tiffany Zhang Page 3 assistance/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,  for Lu Jiang Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF | DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. | | --- | --- | | 510(k) Number (if known) K252992 | | | Device Name CT Rembra RT, CT Areta RT, CT Rembra | | | Indications for Use (Describe) The proposed CT Rembra RT, CT Areta RT, and CT Rembra are Computed Tomography X-Ray System intended to produce images of the head and body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment support, components and accessories. The system is indicated for diagnostic imaging in radiology, head and whole-body X-ray Computed Tomography applications in oncology as part of treatment preparation and radiation therapy planning, vascular, interventional, neurology and cardiology, for patients of all ages. These scanners are intended to be used for diagnostic imaging and for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer*. The screening must be performed within the established inclusion criteria of programs/protocols that have been approved and published by either a governmental body or a professional medical society. *Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information. | | | 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) | | | CONTINUE ON A SEPARATE PAGE IF NEEDED. | | | This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | | | The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov | | | "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | | {4} PHILIPS K252992 510(k) Summary for CT Rembra RT, CT Areta RT, CT Rembra This 510(k) summary is provided in accordance with 21 CFR 807.92(c) and summarizes the information supporting a determination of substantial equivalence. ## Legal Manufacturer Philips Healthcare (Suzhou) Co., Ltd. No. 258, Zhongyuan Road, Suzhou Industrial Park, Suzhou, Jiangsu, CHINA, 215024 Establishment Registration Number: 3009529630 ## Location of Manufacturing Site No. 258, Zhongyuan Road, Suzhou Industrial Park, Suzhou, Jiangsu, CHINA, 215024 Establishment Registration Number: 3009529630 Advanced Technology Center MATAM, Building 34, 3100202 Haifa, Israel Establishment Registration Number: 9617978 ## Submitter Contact Person | Primary Contact | Secondary Contact | | --- | --- | | Tiffany Zhang Regulatory Affairs Manager Phone: +86-0-18911415886 E-mail: tiffany.zhang@philips.com | Carmit Shmuel Regulatory Affairs Manager and Site Lead Phone: (972) 54-2109054 E-mail: Carmit.shmuel@philips.com | ## Device Name and Classification | Commercial/Trade name: | CT Rembra RT | CT Areta RT | CT Rembra | | --- | --- | --- | --- | | Product Name | CT 5400 RT | CT 5200 RT | CT 5400 | | Legal Manufacturer: | Philips Healthcare (Suzhou) Co., Ltd. | | | | Classification Name: | Computed tomography x-ray system | | | | Classification Regulation: | 21 CFR 892.1750 | | | | Classification Panel: | Radiology | | | | Device Class: | II | | | | Primary Product code: | JAK | | | ## Predicate Device Primary Predicate Device: | Trade Name: | CT 5300 | | --- | --- | | Manufacturer: | Philips Healthcare (Suzhou) Co., Ltd. | | 510(k) Clearance: | K232491 | | Classification Regulation: | 21 CFR 892.1750 | {5} PHILIPS | Classification Name: | Computed tomography x-ray system | | --- | --- | | Classification Panel: | Radiology | | Device Class: | II | | Product Code: | JAK | Secondary Predicate Devices: | Trade Name: | Philips CT Big Bore | | --- | --- | | Manufacturer: | Philips Medical Systems Nederland B.V. | | 510(k) Clearance: | K171850 | | Classification Regulation: | 21 CFR 892.1750 | | Classification Name: | Computed tomography x-ray system | | Classification Panel: | Radiology | | Device Class: | II | | Product Code: | JAK | | Trade Name: | Spectral CT 7500 RT | | --- | --- | | Manufacturer: | Philips Medical Systems Nederland B.V. | | 510(k) Clearance: | K240844 | | Classification Regulation: | 21 CFR 892.1750 | | Classification Name: | Computed tomography x-ray system | | Classification Panel: | Radiology | | Device Class: | II | | Product Code: | JAK | Reference device: | Trade Name: | CT Collaboration Live | | --- | --- | | Manufacturer: | Philips Healthcare (Suzhou) Co., Ltd. | | 510(k) Clearance: | K242329 | | Classification Regulation: | 21 CFR 892.2050 21 CFR 892.1750 | | Classification Name: | Medical image management and processing system Computed tomography x-ray system | | Classification Panel: | Radiology | | Device Class: | Class II | | Product Code: | LLZ, JAK | ## Device Description The CT Rembra RT, CT Areta RT, and CT Rembra proposed devices have similar technological characteristics, software operating platform, and supported software characteristics as the predicate devices. The proposed devices expand the CT product family with improved performance, workflow and functionality for oncology applications. They also provide a large-bore radiology solution on the Incisive Host software platform. The design of the proposed CT Rembra RT, CT Areta RT, CT Rembra is based on the currently marketed CT 5300 (K232491), with hardware and software modifications. These include the {6} PHILIPS addition of new oncology software features and workflow enhancements for radiotherapy planning support. The proposed system is a whole-body computed tomography (CT) x-ray system featuring a continuously rotating x-ray tube, detectors, and gantry with multi-slice capability. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. It produces CT images in DICOM format, which can be used by trained staff for post-processing applications commercially distributed by Philips. The CT images can be used by trained staff as an aid in diagnosis, treatment and radiation therapy planning as well as for diagnostic and therapeutic interventions. Only trained and qualified users, certified in accordance with country-specific regulations, are authorized to operate the system. The proposed device has an 85 cm bore and includes a detector array that provides 60 cm scan field of view (SFOV) and 85cm extended field of view (EFOV). The key system modules and functionalities of proposed device are: Gantry [X-ray tube assembly, HV generator, Collimator, DMS (Data Measurement System), Touch Panels], Patient Table (Couch), Console and optional components as well as accessories. This system also includes hardware and software for data acquisition, display, manipulation, storage and filming as well as post-processing into views other than the original axial images. Upgrade Kits are available to upgrade CT Rembra RT, CT Areta RT, CT Rembra installations to the latest version in forward production. ## Indications for Use The proposed CT Rembra RT, CT Areta RT, and CT Rembra are Computed Tomography X-Ray System intended to produce images of the head and body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment support, components and accessories. The system is indicated for diagnostic imaging in radiology, head and whole-body X-ray Computed Tomography applications in oncology as part of treatment preparation and radiation therapy planning, vascular, interventional, neurology and cardiology, for patients of all ages. These scanners are intended to be used for diagnostic imaging and for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer*. The screening must be performed within the established inclusion criteria of programs/protocols that have been approved and published by either a governmental body or a professional medical society. *Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information. ## Indications for Use Comparison The indications for use of the proposed CT Rembra RT, CT Areta RT, and CT Rembra are similar to those of the predicate devices CT 5300 (K232491), Philips CT Big Bore (K171850), and Spectral CT 7500 RT (K240844). All devices are computed tomography (CT) x-ray systems intended to produce cross-sectional images of the head and body by computer reconstruction of x-ray transmission data. The devices are indicated for diagnostic imaging applications, including head and whole-body imaging, and {7} PHILIPS may be used in oncology, vascular, cardiology, and other clinical applications for patients of all ages. The proposed devices additionally include use in oncology applications for treatment preparation and radiation therapy planning, which is consistent with the intended use of the predicate devices. All devices are also intended for low-dose CT lung cancer screening in accordance with established screening protocols. Therefore, the indications for use of the proposed devices are the same as those of the predicate devices, do not raise new questions of safety and effectiveness, and support a determination of substantial equivalence. ## Comparison of Technological Characteristics with Predicate Devices The proposed CT Rembra RT, CT Areta RT, and CT Rembra are computed tomography x-ray systems designed to generate cross-sectional images of the human body through a computer's reconstruction of x-ray transmission data acquired from different angles and planes. The system also includes signal analysis and display equipment, patient and equipment support, components, and accessories. The proposed device is a continuous rotation computed tomography system suitable for a range of CT applications and is used clinically as a diagnostic imaging device that produces images corresponding to tissue density. The quality of the images depends on the level and amount of X-ray energy delivered to the tissue. CT imaging displays both high-density tissue, such as bone, and soft tissue. The technological characteristics of the proposed CT Rembra RT, CT Areta RT, CT Rembra, were compared with those of the predicate devices CT5300 (K232491), Philips CT Big Bore (K171850), and Spectral CT 7500 RT (K240844). The comparison includes the following categories: - Scanner - Technical basis (Single/Dual layer, etc.) - Environment of Use - Patient Population - Application body sites - Kind of users - Hardware property - Gantry - Patient table (Couch) - Generator and Tube - DMS - Console - Software property - Software release version - Software features The proposed devices have the same fundamental technological characteristics as the predicate devices. Software features of CT Rembra RT, CT Areta RT, and CT rembra have been modified compared to the predicate devices to support additional device functionality. The updated software reuses previously cleared unmodified software features from the legacy software cleared under K232491, K171850, K240844 and K242329. 4 {8} PHILIPS Based on the comparison of technological characteristics, the proposed CT Rembra RT, CT Areta RT, and CT Rembra do not raise new questions of safety and effectiveness and support a determination that the proposed devices are substantially equivalent to the predicate devices CT5300 (K232491), Philips CT Big Bore (K171850), and Spectral CT 7500 RT (K240844). ## Substantial Equivalence A summary of the technological characteristics of the proposed devices, CT Rembra RT, CT Areta RT, and CT Rembra, and their comparison to the predicate devices, CT5300 (K232491), Philips CT Big Bore (K171850), and Spectral CT 7500 RT (K240844) is provided in Table 1. Table 1. Summary of Technological Comparison and Basis for Substantial Equivalence | Category | Proposed Devices | Predicate Device(s) | Basis for Substantial Equivalence | | --- | --- | --- | --- | | Core technology | Whole-body CT x-ray system with continuous rotation | CT5300 | Same fundamental technology | | Technical basis | Single-layer detector system | CT5300 | Same technological characteristics | | Use environment, users, and patient population | Hospital use; trained operators; patients of all ages | CT5300 | Comparable | | Clinical applications | Diagnostic imaging including oncology and radiation therapy planning | CT5300, Philips CT Big Bore, Spectral CT 7500 RT | Comparable intended use | | Scan operation | Continuous rotation; axial and helical scan modes | CT5300 | Same fundamental operation | | System architecture | Gantry, tube, detector, couch, console | CT5300 | Same fundamental design | | Performance characteristics | Image quality, noise, slice thickness, dose management | CT5300 | Comparable performance | | Dose management and standards | Complies with applicable NEMA and regulatory standards | CT5300 | Comparable | | Software platform | Incisive Host Platform (updated version) | CT5300 (prior version) | Modified; supported by verification and validation testing | | Bore size / geometry | 85 cm bore | Philips CT Big Bore | Comparable design supported by predicate | | Field of view (EFOV) | Up to 85 cm EFOV | Philips CT Big Bore, Spectral CT 7500 RT | Modified; supported by predicate technology and testing | | Image resolution | Improved high-resolution performance | CT5300 | Modified; supported by testing | | Detector | Updated detector elements | CT5300 | Modified; supported | {9} PHILIPS | configuration | | | by testing | | --- | --- | --- | --- | | Oncology / RT workflow | OnPlan and RT workflow enhancements | CT 5300, Spectral CT 7500 RT, Philips CT Big Bore | Comparable functionality | | Advanced imaging features | Pulmonary gating (4D CT) Extended field of view (EFOV), CT Collaboration Live, Precise Position, Precise Intervention | CT 5300, Spectral CT 7500 RT, Philips CT Big Bore | Comparable functionality | | New software features | MM Sim auto-launch, CANOpen injection, Body perfusion | Not present in predicate devices | New features supported by verification and validation testing | The proposed CT Rembra RT, CT Areta RT, and CT Rembra have the same intended use and the same fundamental technological characteristics as the predicate devices CT5300 (K232491), Philips CT Big Bore (K171850), and Spectral CT 7500 RT (K240844). Differences in technological characteristics, including hardware modifications, software updates, and additional features, are supported by non-clinical performance testing or are comparable to features in the predicate devices. These differences do not raise new questions of safety and effectiveness and support a determination that the proposed devices are substantially equivalent to the predicate devices. ## Performance Data The non-clinical performance testing, including system and sub-system, phantom testing, cybersecurity, usability, interoperability, IEC/EMC and external IQ assessment, was conducted for the proposed CT Rembra RT, CT Areta RT, and CT Rembra during product development. These testing activities support the modifications described in this Premarket Notification and were conducted to demonstrate that the proposed devices are as safe and effective as the predicate devices. Non-clinical performance testing demonstrates compliance with applicable international standards, FDA-recognized consensus standards, and regulatory requirements. The following standards were applied, as appropriate, to support the evaluation of device safety and performance: Table 2. Applicable Standards | Standard | Title / Description | FDA Recognition Number | | --- | --- | --- | | AAMI / ANSI ES60601-1:2005/(R)2012 + amendments (Incl. AMD2:2021) | Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance (IEC 60601-1:2005, MOD) | 19-46 | 6 {10} PHILIPS | IEC 60601-1-2 Ed. 4.1 (2020) | Medical Electrical Equipment – Electromagnetic disturbances (EMC) requirements and tests | 19-36 | | --- | --- | --- | | IEC 60601-1-3 Ed. 2.2 (2021) | Radiation protection in diagnostic X-ray equipment | 12-336 | | IEC 60601-1-6 Ed. 3.2 (2020) | Usability engineering for medical electrical equipment | 5-132 | | IEC 60601-2-44 Ed. 3.2 (2016) | Particular requirements for CT equipment safety and performance | 12-302 | | IEC 62304 Ed. 1.1 (2015) | Medical device software – Software lifecycle processes | 13-79 | | IEC 62366-1 Ed. 1.1 (2020) | Application of usability engineering to medical devices | 5-129 | | ISO 14971 (2019) | Application of risk management to medical devices | 5-125 | | ISO 10993-1 (2018) | Biological evaluation of medical devices – Part 1 | 2-258 | | NEMA XR 25-2019 | CT Dose Check | 12-325 | | NEMA XR 26:2020 | Access Controls for CT: Identification, Interlocks, and Logs | — | | NEMA XR 28-2018 (R2023) | User information and system function related to dose in CT | 12-330 | | NEMA XR 29-2013 | Standard attributes related to dose optimization and management | — | Table 3. Applicable Guidance Documents | Guidance Document | Issue Date | | --- | --- | | Guidance for the Content of Premarket Submissions for Device Software Functions | June 14, 2023 | | Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices | Sep 6, 2017 | | Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions | June 27, 2025 | | Pediatric Information for X-ray Imaging Device Premarket Notifications | Nov 28, 2017 | | Applying Human Factors and Usability Engineering to Medical Devices | Feb 3, 2016 | | Medical X-Ray Imaging Devices Conformance with IEC Standards | Feb 21, 2023 | | Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices | Sep 14, 2018 | | Electromagnetic Compatibility (EMC) of Medical Devices | June 6, 2022 | | Performance Standards for CT Equipment and Laser Products (21 CFR 1020.33 and 21 CFR 1040.10) | — | | Use of International Standard ISO 10993-1 | Sep 8, 2023 | Verification and Validation Detailed verification and validation (V&V) results are provided in the full system and sub-system reports included in this submission. Verification and validation activities, including software verification, risk management, and design validation, demonstrate that the proposed CT Rembra {11} PHILIPS RT, CT Areta RT, and CT Rembra meet design input requirements and perform as intended for their clinical workflow and intended use. ## Additional Non-Clinical Performance Testing Additional non-clinical performance testing was conducted to support new and modified features, including pulmonary gating (4D CT), extended field of view (EFOV), body perfusion, MM Sim auto-launch, OnPlan, and CANOpen injection. These evaluations included phantom testing, system verification and validation, and external image quality assessment, as applicable, and demonstrated acceptable performance for the intended use. ## Bench Testing Summary Table 4. Summary of Non-Clinical Performance Testing | Feature | Testing Performed | Summary of Results | | --- | --- | --- | | Pulmonary Gating (4D CT) | Phantom testing, system V&V, external image quality review | Demonstrated acceptable image quality and reduced motion artifacts for intended use | | Extended Field of View (EFOV) | Phantom testing, system V&V, external image quality review | Demonstrated acceptable geometric and quantitative accuracy for RT planning applications | | Body Perfusion, MM Sim auto-launch, OnPlan | System V&V | Demonstrated acceptable performance for intended use | | CANOpen Injection | Subsystem and system V&V | Demonstrated acceptable performance for intended use | The non-clinical performance testing supports the determination of substantial equivalence and demonstrates that the proposed CT Rembra RT, CT Areta RT, and CT Rembra: - Comply with applicable standards and guidance; and - Meet predefined acceptance criteria for their intended use. The proposed devices did not require clinical studies, as substantial equivalence to the predicate devices CT5300 (K232491), Philips CT Big Bore (K171850), and Spectral CT 7500 RT (K240844) was demonstrated based on: - Indications for use; - Technological characteristics; and - Non-clinical performance testing. Differences in technological characteristics are supported by non-clinical performance data and do not raise new questions of safety and effectiveness. These results support a determination that the proposed CT Rembra RT, CT Areta RT, and CT Rembra are substantially equivalent to the predicate devices. ## Cybersecurity Cybersecurity risk management and testing were conducted in accordance with applicable FDA guidance, including Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions. 8 {12} PHILIPS A risk-based approach was applied to identify potential cybersecurity threats and vulnerabilities. Appropriate risk control measures were implemented and verified through system and sub-system level testing, including vulnerability assessment and testing. Cybersecurity verification and validation activities demonstrate that the proposed devices are designed to protect against unauthorized access and maintain the confidentiality, integrity, and availability of system data. These activities support that the proposed devices do not raise new questions of safety and effectiveness and support a determination of substantial equivalence. ## Conclusions The non-clinical data support the substantial equivalence of the proposed devices. Hardware and software verification and validation demonstrate that the CT Rembra RT, CT Areta RT, and CT Rembra perform as intended in the specified use conditions. The data included in this submission demonstrate that the proposed devices are as safe and effective as the predicate devices and support a determination of substantial equivalence. 9