← Product Code [QIH](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/QIH) · K254184 # syngo Application Software (K254184) _Siemens Medical Solutions USA, Inc. · QIH · Apr 29, 2026 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/QIH/K254184 ## Device Facts - **Applicant:** Siemens Medical Solutions USA, Inc. - **Product Code:** [QIH](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/QIH.md) - **Decision Date:** Apr 29, 2026 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.2050 - **Device Class:** Class 2 - **Review Panel:** Radiology - **Attributes:** AI/ML ## Indications for Use The syngo Application Software is a medical software for real-time viewing, image manipulation, 3D visualization, communication, and storage of medical images and data on exchange media. It is used for diagnostic image viewing and postprocessing and for viewing and postprocessing during interventional procedures. The syngo Application Software can be deployed on independent hardware such as a stand-alone diagnostic review, postprocessing, and reporting workstation. It can also be configured within a network to send and receive DICOM data. Furthermore, the syngo Application Software can be deployed on systems of the Siemens Healthineers Angiography system family. It provides image guided solutions in the operating room, for image guided surgery, by image fusion and by navigation systems, image guided solutions in interventional cardiology and electrophysiology and image guided solutions for interventional oncology, interventional radiology, and interventional neuroradiology. The syngo Application Software can also be combined with fluoroscopy systems or radiographic systems. The syngo Application Software can be configured with a variety of syngo or Windows-based software options, which are intended to assist the physician in diagnosis, treatment planning and treatment control. It includes commercially available postprocessing techniques and OEM options. Procedures that can be performed include: minimally invasive surgical procedures and minimally invasive tumor treatment. ## Device Story Medical software for real-time viewing, 3D visualization, and post-processing of digital radiographic, fluoroscopic, and angiographic images; operates on standalone workstations or integrated into Siemens angiography/imaging systems. Inputs include DICOM medical images; outputs include processed 3D volumes, overlays, and navigation guidance. Used by physicians (surgeons, interventionalists) in ORs, interventional suites, and clinics for diagnosis, treatment planning, and guidance. Features include myScrew Path Assist for pedicle screw placement; Embolization Guidance for target/feeder vessel identification; TrueFusion for ultrasound/angiography image overlay; CleanEdge for noise reduction; DynaCT Bone Removal for automated segmentation; and DynaCT MORE for motion-compensated reconstruction. Output displayed on clinical monitors or ARTIS Touch UI; assists clinicians in minimally invasive procedures by providing enhanced visualization and navigation, potentially improving procedural accuracy and efficiency. ## Clinical Evidence Bench testing only. DynaCT Bone Removal validated on 180 test cases (mean Dice 0.95, IoU 0.90) and 370 clinical datasets (100% success rate). DynaCT MORE validated on 40 liver datasets; 100% acceptance rate for image quality/diagnostic utility by two independent readers; no inferior ratings in secondary parameters (sharpness, contrast, artifacts). ## Technological Characteristics Software-based medical image management and processing system. Connectivity via DICOM; supports TLS 1.3. Features include non-linear smoothing filters (CleanEdge), AI-based segmentation (DynaCT Bone Removal), and motion compensation algorithms (DynaCT MORE). Complies with ISO 14971, IEC 62304, IEC 62366-1, and cybersecurity standards (IEC 81001-5-1, UL 2900-1/2-1). ## Regulatory Identification A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements. ## Special Controls *Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern). ## Predicate Devices - syngo Application Software ([K241569](/device/K241569.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} FDA U.S. FOOD & DRUG ADMINISTRATION April 29, 2026 Siemens Medical Solutions USA, Inc. % Patricia Jones Regulatory Affairs Professional 40 Liberty Blvd. MALVERN, PA 19355 Re: K254184 Trade/Device Name: syngo Application Software Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: QIH Dated: December 23, 2025 Received: March 23, 2026 Dear Patricia Jones: 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K254184 – Patricia Jones 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 13484 clause 8.3 (Nonconforming product), and ISO 13485 clause 8.5 (Corrective and 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 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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} K254184 – Patricia Jones 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, ![img-0.jpeg](img-0.jpeg) 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 PXC 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) K254184 | | | Device Name syngo Application Software | | | Indications for Use (Describe) The syngo Application Software is a medical software for real-time viewing, image manipulation, 3Dvisualization, communication, and storage of medical images and data on exchange media. It is used for diagnostic image viewing and postprocessing and for viewing and postprocessing during interventional procedures. The syngo Application Software can be deployed on independent hardware such as a stand-alone diagnostic review, postprocessing, and reporting workstation. It can also be configured within a network to send and receive DICOM data. Furthermore, the syngo Application Software can be deployed on systems of the Siemens Healthineers Angiography system family. It provides image guided solutions in the operating room, for image guided surgery, by image fusion and by navigation systems, image guided solutions in interventional cardiology and electrophysiology and image guided solutions for interventional oncology, interventional radiology, and interventional neuroradiology. The syngo Application Software can also be combined with fluoroscopy systems or radiographic systems. The syngo Application Software can be configured with a variety of syngo or Windows-based software options, which are intended to assist the physician in diagnosis, treatment planning and treatment control. It includes commercially available postprocessing techniques and OEM options. Procedures that can be performed include: minimally invasive surgical procedures and minimally invasive tumor treatment. | | | 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} SIEMENS Healthineers 510(k) Summary: syngo Application Software 510(k) #: K254184 Company: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, Malvern, PA 19355 Date of Preparation: April 27, 2026 This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92. 1. General Information: Importer / Distributor: Siemens Medical Systems USA, Inc. 40 Liberty Boulevard, Malvern, PA 19355 Establishment Registration Number: 2240869 Manufacturing Site: Siemens Healthineers AG Siemensstr. 1 91301 Forchheim, Germany Establishment Registration Number: 3004977335 2. Contact Person: Ms. Patricia D Jones Regulatory Affairs Professional Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Phone: (678) 575-8832 Email: patricia.jones@siemens-healthineers.com 3. Device Name and Classification: Trade Name: syngo Application Software Classification Name: Medical Image Management and Processing System Classification Panel: Radiology Classification Regulation: 21 CFR 892.2050 Device Class: Class II Product Code: QIH 4. Legally Marketed Predicate Device Trade Name: syngo Application Software 510(k) Clearance K241569 Clearance Date 10/11/2024 Page 1 of 9 {5} SIEMENS Healthineers Classification Name: Medical Image Management and Processing System Classification Panel: Radiology Classification Regulation: 21 CFR 892.2050 Device Class: Class II Product Code: LLZ Recall Information: This predicate device has not been the subject of any design-related recalls. # 5. Device Description: The "syngo Application Software" is medical diagnostic software for real-time viewing, diagnostic review, post-processing image manipulation, optimization, communication, reporting, and storage of medical images and data on exchange media. It provides image-guided solutions in the operating room, for image-guided surgery, by Image Fusion and by navigation systems, image-guided solutions in interventional cardiology and electrophysiology, and image-guided solutions for interventional oncology, interventional radiology, and interventional neuroradiology. It can be deployed with a variety of syngo or Windows-based software options, which are intended to assist the physician in the evaluation of digital radiographic examinations, including diagnosis and/or treatment planning. Siemens "syngo Application Software" is designed to work with digital radiographic, fluoroscopic, interventional, and angiographic systems. Siemens Medical Solutions USA, Inc. hereby submits this Traditional 510(k) to request clearance to market the following modifications: List of Modifications: 1) Updated Software VE40C to VE51A A. New Updated myScrew Path Assist B. Updated syngo Embolization Guidance user interface C. Updated syngo TrueFusion D. New feature "CleanEdge" E. New syngo DynaCT Bone Removal F. New syngo DynaCT MORE G. Updated Contour Enhanced Overlay H. Updated QuantWeb and 3D volumes feature for visual display on ARTIS Touch UI 2). Product Claims List The "syngo Application Software" may be installed either on Siemens released PC hardware, on Siemens X-ray systems, or on Siemens angiography systems. The "syngo Application Software" is within the same classification regulation and the intended use and the general Indications for Use Statement for Siemens' Medical Image Management and Processing System remains the same Page 2 of 9 {6} SIEMENS Healthineers ## 6. Indications for Use: The syngo Application Software is a medical software for real-time viewing, image manipulation, 3D visualization, communication, and storage of medical images and data on exchange media. It is used for diagnostic image viewing and postprocessing and for viewing and postprocessing during interventional procedures. The syngo Application Software can be deployed on independent hardware such as a stand-alone diagnostic review, postprocessing, and reporting workstation. It can also be configured within a network to send and receive DICOM data. Furthermore, the syngo Application Software can be deployed on systems of the Siemens Healthineers Angiography system family. It provides image-guided solutions in the operating room, for image-guided surgery, by image fusion and by navigation systems, image-guided solutions in interventional cardiology and electrophysiology, and image-guided solutions for interventional oncology, interventional radiology, and interventional neuroradiology. The syngo Application Software can also be combined with fluoroscopy systems or radiographic systems. The syngo Application Software can be configured with a variety of syngo or Windows-based software options, which are intended to assist the physician in the diagnosis, treatment planning, and treatment control. It includes commercially available postprocessing techniques and OEM options. Procedures that can be performed include: minimally invasive surgical procedures and minimally invasive tumor treatment. ## 7. Summary of Technological Characteristics of the Subject Device as Compared with the Predicate Device: The subject device has the same intended use as the predicate device. Besides the proposed device modifications, the Subject Device has the same functionality and technology. All software components of the subject device are the same as the ones from the predicate device except for the new optional software applications as presented in the table below: The Subject Device modifications do not alter the fundamental scientific technology from the 510(k) cleared predicate device Siemens' "syngo Application Software" (VE40C), K241569. Page 3 of 9 {7} SIEMENS Healthineers | Modifications | Subject Device syngo Application Software (VE51A) | Predicate Device syngo Application Software (VE40C) K241569 | Comparison Results | | --- | --- | --- | --- | | New System Software/ Changes | 1. Updated syngo Application Software from VE40C to VE51A | syngo Application Software VE40C | The VE51 Software contains new /updated features A-H. | | | A. New Updated myScrew Path Assist | N/A | The New Updated myScrew Path Assist is a medical software module intended to be used primarily by spine surgeons to facilitate the placement of devices such as screws and K-wires in the patients' spine pedicles for a range of different indications. | | | B. Updated syngo Embolization Guidance user interface | syngo Embolization Guidance | 1. Interactive display of target measurements (diameter and volume) 2. Updated user interface designed with focus on clinical ease-of-use 3. Three workflows addressing specific clinical use-cases 4. Centerline color scheme visually linking targets with respective feeders. | | | C. Updated syngo TrueFusion | syngo TrueFusion | 1. The communication between ultrasound and angiography systems complies with IT requirements and is secured using a valid SSL/TLS certificate issued by a trusted Certificate Authority (CA). TLS version 1.3 is set as the minimum supported version. 2. The fused image is displayed directly on the ultrasound system screen, allowing the echocardiographer to view both the ultrasound and TrueFusion overlay simultaneously | | | D. New feature "CleanEdge" | N/A | Postprocessing option for head DynaCT volume data. It reduces noise and high frequency artifacts in 3D head data by a non-linear smoothing filter. | | | E. New syngo DynaCT Bone Removal | N/A | Provides automatic calculation and cropping of bony structure from thoracic, abdominal, and pelvic syngo DynaCT volume datasets of adult patients | | | F. New syngo DynaCT MORE | N/A | syngo DynaCT MORE is intended to estimate the motion using the acquired image data | Page 4 of 9 {8} SIEMENS Healthineers | Modifications | Subject Device syngo Application Software (VE51A) | Predicate Device syngo Application Software (VE40C) K241569 | Comparison Results | | --- | --- | --- | --- | | | | | and to compensate the motion during the 3D reconstruction | | | G. Updated Contour Enhanced Overlay | Contour Enhanced Overlay | The Contour Enhanced Overlay parameter set within the “Light Enhancement Features” has been added to the preset gallery for VRT images. | | | H. Updated QuantWeb and 3D volumes feature for visual display on ARTIS Touch UI | QuantWeb and 3D volumes | Quantweb is now accessible by tableside using the ARTIS Touch Interface. VE51A software also enables direct interaction with 3D volumes via touch User Interface. | | | 2. Product Claims List | | | # 8. Nonclinical Performance Testing: Non-clinical tests were conducted for the "syngo Application Software" during product development. Siemens claims conformance to the following performance standards: | Recognition Number | Product Area | Title of Standard | Reference Number and Date | Publication Date | Standards Development Organization | | --- | --- | --- | --- | --- | --- | | 5-125 | General | Medical devices - Application of risk management to medical devices | 14971 | 2019 | ISO | | 5-134 | General | Medical devices - Symbols to be used with medical device labels, labeling, and information to be supplied - Part 1: General requirements | 15223-1 | 2021 | ISO | | 5-135 | General | Medical devices -Information to be supplied by the manufacturer | 20417-First edition 2021-04 Corrected version 2021-12 | 2021 | ISO | | 13-97 | Software/ Informatics | Health software - Part 1: General requirements for product safety | 82304-1 | 2016 | IEC | | 13-79 | Software/ Informatics | Medical Device Software - Software life-cycle process | 62304 | 2015 | IEC | Page 5 of 9 {9} SIEMENS Healthineers | Recognition Number | Product Area | Title of Standard | Reference Number and Date | Publication Date | Standards Development Organization | | --- | --- | --- | --- | --- | --- | | 5-129 | General | Medical devices - Part 1 Application of usability engineering to medical devices | 62366-1 | 2020 | IEC | | 13-38 | Software/Informatics | Application of risk management for IT - networks incorporating medical devices - Part 1: Roles, responsibilities, and activities | 80001-1 | 2010 | IEC | | 13-122 | Software/Informatics | Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle | 81001-5-1 | 2021 | IEC | | 12-363 | Radiology | Digital Imaging and Communications in Medicine (DICOM) Set | PS 3.1 – 3.20 2024e | 2024 | NEMA | | 13-96 | Software/Informatics | Standard for Safety, Standard for Software Cybersecurity Network-Connectable Products, Part 1: General Requirements | 2900-1 | 2017 | ANSI UL | | 13-104 | Software/Informatics | Standard for Safety, Software Cybersecurity for Network-Connectable Products, Part 2-1: Particular Requirements for Network Connectable Components of Healthcare and Wellness Systems | 2900-2-1 | 2017 | ANSI UL | | 13-83 | Software/Informatics | Principles for medical device security – Risk management | TIR57 | 2016 | AAMI | | 13-143 | Software/Informatics | Guidance on the use of AGILE practices in the development of medical device software | TIR45 | 2023 | AAMI | | 13-131 | Software/Informatics | Standard for medical device security – Security risk management for device manufacturers | SW96 | 2023 | ANSI AAMI | The modifications described in this Premarket Notification are supported with verification and validation testing. Page 6 of 9 {10} SIEMENS Healthineers # Software Verification and Validation: Software documentation for a Basic Documentation Level software per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Device Software Functions" issued on June 14, 2023, and "Off-The-Shelf Software Use in Medical Devices" is also included as part of this submission. Non-clinical tests were conducted on "syngo Application Software" during product development. The Risk analysis was completed, and risk control was implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria. Testing for verification and validation of the device was found acceptable to support the claims of substantial equivalence. The Human Factor Usability Validation showed no safety-relevant functions that need to be validated with a summative usability validation according to the IEC and FDA Guidelines. "syngo Application Software" is safe and effective for intended users, uses, and use environments through the design control verification and validation process. No further risk mitigations are necessary. Siemens conforms to the cybersecurity requirements by implementing a process of preventing unauthorized access, modifications, misuse, or denial of use, or the unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient. Provided in this submission is a cybersecurity statement that considers IEC 80001-1:2010. The responsibility for compliance with IEC 80001-1:2010 is the hospital. Provided in the Software Section is the required cybersecurity information. # Summary of Performance Testing Data: Tests were conducted in support of the new/updated functionalities for the "syngo Application Software": New Updated myScrew Path Assist testing encompassed basic functional aspects of 3D3D lab registration; acquisition wizard, 3D calibration process, image flip and name of vertebra, image capture functionality with overlay assist, basic flow screw planning, and basic flow spine guidance. The updated syngo Embolization Guidance workflow was tested to validate that myEmbolization Guide provides semi-automatic identification of target structures, feeder vessels, and supports precise device navigation for embolization by overlaying planning information. Updated syngo TrueFusion workflow was tested to check for overlay on live 2D image on the ultrasound and vice versa and checks that probe markers are considered for probe registration. New feature "CleanEdge" was tested to ensure Interactive reconstruction is performed using the Clean Edge functionality to reduce the white noise and the edges of the structures are clear with focus on usage of the Image Correction Algorithms for different Page 7 of 9 {11} SIEMENS Healthineers system and detector types, and checks that CleanEdge functionality is only available for specific reconstruction mode. ## New syngo DynaCT Bone Removal: Quantitative segmentation accuracy was assessed through voxel-wise comparison of AI-generated bone masks against expert reference (ground truth) bone masks. Ground truth masks were created for 180 test cases. The test cohort was balanced by anatomical region, comprising 60 cases each for the thorax, abdomen, and pelvis. AI-generated bone masks were compared voxel-wise with the expert reference masks to calculate overlap-based segmentation accuracy metrics. Quantitative results demonstrated close agreement with expert delineations, achieving a mean Dice similarity coefficient of approximately $0.95 \pm 0.02$ and a mean intersection-over-union (IoU) of approximately $0.90 \pm 0.03$ across the 180-case test set. In addition to quantitative metrics, a clinical reader evaluation was conducted on 370 datasets acquired in the United States and Europe. Subgroup analyses were performed based on gender, age, body mass index (BMI), patient size, and data source. The clinical validation demonstrated an overall bone mask success rate of $100\%$ (370/370 datasets), based on merged reader assessments. Furthermore, an overall vessel assessment improvement rate of $100\%$ (304/304 contrast-enhanced datasets) was observed, as determined by majority reader vote. In conclusion, these quantitative and clinical evaluation results support that the AI-generated bone masks are complete and reliable and that their use improves vessel assessment within the intended anatomical regions. ## New syngo DynaCT MORE: A retrospective comparative assessment of image quality and diagnostic utility was performed by clinical experts using DynaCT acquisitions reconstructed with and without syngo DynaCT MORE. A total of 40 liver datasets were included in the analysis. Data from both female and male patients were evaluated. The mean patient age was $69 \pm 10$ years, with an age range of 30 to 85 years. Body mass index (BMI) was available for 18 datasets and ranged from 16.5 to 45.2. For the primary analysis, the acceptance rate for final image quality and diagnostic utility was evaluated. For each dataset, two independent readers assessed whether image quality and diagnostic utility after reconstruction with syngo DynaCT MORE were basically inferior (score 1), basically equivalent (score 2), or obviously better (score 3) compared with a conventional reconstruction. Sufficient image quality and diagnostic utility were defined as both readers rating each dataset as non-inferior (score 2 or 3). Based on the observed data, all 40 datasets were rated as non-inferior by both readers, resulting in an acceptance rate of $100\%$. Therefore, the predefined primary acceptance criterion was met. For the secondary and further analyses, image sharpness, image contrast, artifact occurrence, and diagnostic confidence after reconstruction with syngo DynaCT MORE Page 8 of 9 {12} SIEMENS Healthineers were assessed in comparison with a conventional reconstruction using a 5-point rating scale. No inferior ratings (scores 1 or 2) were assigned for any of the evaluated parameters across all assessments. Furthermore, after reconstruction with syngo DynaCT MORE, no loss of anatomical structures was identified by the readers in any of the 120 assessments. In conclusion, the acceptance criteria were met for both the primary and secondary analyses Updated Contour Enhanced Overlay workflow was tested to achieve an optimal visualization of the overlay by adjusting contour enhancement functionality. Updated QuantWeb and 3D volumes feature for visual display on ARTIS Touch UI workflow was tested to validate that Quant functionality is available and fully functional on the system and can be operated via control room and exam room on ARTIS Touch UI. Performance tests were conducted to test the functionality of the "syngo Application Software. The results of all conducted testing were found acceptable and did not raise any new issues of safety or effectiveness. All software validation data demonstrates that the Subject Device is as safe and effective when compared to the Predicate Device that is currently marketed for the same intended use. 9. General Safety and Effectiveness Concerns: Instructions for use are included within the device labeling, and the information provided will enable the user to operate the device safely and effectively. Risk management is ensured via a hazard analysis, which is used to identify potential hazards. These potential hazards are controlled via software development, verification, and validation testing. Furthermore, the operators are healthcare professionals familiar with and responsible for the evaluation and post-processing of medical images. 10. Conclusion as to Substantial Equivalence: The comparison of technological characteristics, non-clinical performance data, clinical images, and software validation data demonstrates that the subject device is substantially equivalent to the predicate device that is currently marketed for the same intended use. Page 9 of 9 --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/QIH/K254184](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/QIH/K254184) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com