Who is the manufacturer of Syngo Carbon Clinicals?

Siemens Healthcare GmbH filed the 510(k) submission for Syngo Carbon Clinicals (K232856).

What is the FDA product code for Syngo Carbon Clinicals?

QIH. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for Syngo Carbon Clinicals?

510(k) clearance (submission type: Traditional).

Does Syngo Carbon Clinicals use AI or machine learning?

Yes. Syngo Carbon Clinicals (K232856) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

Who can help prepare an FDA 510(k) submission like Syngo Carbon Clinicals?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like Syngo Carbon Clinicals get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

Syngo Carbon Clinicals

K232856 · Siemens Healthcare GmbH · QIH · Dec 1, 2023 · Radiology

Device Facts

Record ID	K232856
Device Name	Syngo Carbon Clinicals
Applicant	Siemens Healthcare GmbH
Product Code	QIH · Radiology
Decision Date	Dec 1, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device

Intended Use

Syngo Carbon Clinicals is intended to provide advanced visualization tools to prepare and process the medical image for evaluation, manipulation and communication of clinical data that was acquired by the medical imaging modalities (for example, CT, MR, etc.) The software package is designed to support technicians and physicians in qualitative and quantitative measurements and in the analysis of clinical data that was acquired by medical imaging modalities. An interface shall enable the connection between the Syngo Carbon Clinicals software package and the interconnected software solution for viewing, manipulation, communication, and storage of medical images.

Device Story

Syngo Carbon Clinicals is a software-only plug-in for SYNGO-based hosting applications (e.g., Syngo Carbon Space, syngo.via). It provides advanced visualization and measurement tools for diagnostic reading of medical images (CT, MR). Input consists of medical images from the hosting application; output includes processed renderings, measurements, and analysis data. Used in radiology and oncology clinics by physicians and technicians. The device performs cinematic rendering (Cinematic Insight), manual calibration, and oncological evaluation (lesion quantification, perpendicular measurements, lung nodule marking). It relies on the hosting application for image communication, GUI, and archiving. It does not perform automated diagnostic interpretation. Benefits include enhanced visualization and standardized measurement capabilities to support clinical evaluation.

Clinical Evidence

Bench testing only. No clinical studies performed. Verification and validation activities included phantom and reader studies for Lesion Quantification and Organ Segmentation algorithms, leveraging data from predicate and reference devices. Software verification and validation confirmed all specifications met acceptance criteria.

Technological Characteristics

Software-only plug-in; layered modular architecture. Features: Cinematic rendering (cVRT), manual calibration, lesion quantification, and lung nodule marking. Connectivity: Integrated via host application. Standards: ISO 14971:2019, IEC 62304:2015, IEC 82304-1:2016, IEC 62366-1:2020. Software level of concern: Moderate.

Indications for Use

Indicated for technicians and physicians requiring advanced visualization, qualitative/quantitative measurement, and analysis of clinical data acquired by medical imaging modalities (e.g., CT, MR). Not indicated for mammography diagnosis in the U.S. Not for use as a sole basis for clinical decisions.

Regulatory Classification

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 Carbon Space (K230561)

Reference Devices

syngo.via RT Image Suite (K220783)
syngo.via (K191040)
syngo.CT Lung CAD (K231157)

Related Devices

K251059 — Syngo Carbon Clinicals (VA41) · Siemens Healthineers AG · Oct 24, 2025
K192402 — syngo.CT Extended Functionality · Siemens Medical Solutions USA, Inc. · Sep 20, 2019
K163341 — syngo.CT Extended Functionality · Siemens Medical Solutions USA, Inc. · Feb 9, 2017
K173625 — syngo.CT Clinical Extensions · Siemens Medical Solutions USA, Inc. · Mar 8, 2018
K232136 — syngo.CT Applications · Siemens Medical Solutions USA, Inc. · Jan 4, 2024

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized human figure. The FDA logo is on the right and includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. Siemens Healthcare GmbH Vijay Ramadas Regulatory Affairs Manager Siemensstraße 3 Forchheim, Bayern 91301 Germany Re: K232856 December 1, 2023 Trade/Device Name: Syngo Carbon Clinicals Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: QIH Dated: November 14, 2023 Received: November 14, 2023 Dear Ramadas Ramadas: 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. 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). {1}------------------------------------------------ Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 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 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-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 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. 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-device-safety/medical-device-reportingmdr-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/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, Jessica Lamb Jessica Lamb Assistant Director DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health {2}------------------------------------------------ # Indications for Use Submission Number (if known) K232856 Device Name Syngo Carbon Clinicals #### Indications for Use (Describe) Syngo Carbon Clinicals is intended to provide advanced visualization tools to prepare and process the medical image for evaluation, manipulation and communication of clinical data that was acquired by the medical imaging modalities (for example, CT, MR, etc.) The software package is designed to support technicians and physicians in qualitative and quantitative measurements and in the analysis of clinical data that was acquired by medical imaging modalities. An interface shall enable the connection between the Syngo Carbon Clinicals software package and the interconnected software solution for viewing, manipulation, and storage of medical images. 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." {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" is a design of orange dots. September 15, 2023 # Traditional 510(k) Summary This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92. #### 1. Submitter: Siemens Healthcare GmbH Henkestrasse 127 91052 Erlangen Germany ### 2. Establishment Registration Number: 3004977335 ### 3. Contact Person: Mr. Vijay Ramadas Regulatory Affairs Manager Siemens Healthcare GmbH. Siemensstr. 3 91301 Forchheim Germany E-mail: vijay.ramadas@siemens-healthineers.com Telephone: +49 (172) 4324369 +49 (9191) 18-4404 Fax: #### 4. Device Name and Classification | Device/Trade Name: | Syngo Carbon Clinicals | |------------------------|------------------------------------------------| | Classification Panel: | Radiology Devices | | Classification Number: | 21 CFR 892.2050 | | Classification Name: | Medical Image Management and Processing System | | Device Class: | Class II | | Product Code: | QIH | ### 5. Predicate Device(s): ### Main Predicate Device | Device/Trade Name: | Syngo Carbon Space | |------------------------|------------------------------------------------| | 510(k) Clearance: | K230561 | | Classification Panel: | Radiology Devices | | Classification Number: | 21 CFR 892.2050 | | Classification Name: | Medical Image Management and Processing System | | Device Class: | Class II | | Product Code: | LLZ | {4}------------------------------------------------ ## Reference Device 1 | Device/Trade Name: | syngo.via RT Image Suite | |------------------------|---------------------------------------------------| | 510(k) Clearance: | K220783 | | Classification Panel: | Radiology Devices | | Classification Number: | 21 CFR 892.5050 | | Classification Name: | Medical Charged-Particle Radiation Therapy System | | Device Class: | Class II | | Product Code: | MUJ | ### Reference Device 2 Device/Trade Name: 510(k) Clearance: Classification Panel: Classification Number: Classification Name: Device Class: Product Code: syngo.via K191040 Radiology Devices 21 CFR 892.2050 Medical Image Management and Processing System Class II LLZ ## Reference Device 3 Device/Trade Name: 510(k) Clearance: Classification Panel: Classification Number: Classification Name: Device Class: Product Code: syngo.CT Lung CAD K231157 Radiology Devices 21 CFR 892.2050 Medical Image Management and Processing System Class II OEB ## 6. Device Description: Syngo Carbon Clinicals is a software only Medical Device, which provides dedicated advanced imaging tools for diagnostic reading. These tools can be called up using standard interfaces any native/syngo based viewing applications (hosting applications) that is part of the SYNGO medical device portfolio. These tools help prepare and process the medical image for evaluation, manipulation and communication of clinical data that was acquired by medical imaging modalities (e.g., MR, CT etc.) Deployment Scenario: Syngo Carbon Clinicals is a plug-in that can be added to any SYNGO based hosting applications (for example: Syngo Carbon Space, syngo.via etc...). The hosting application (native/syngo Platform-based software) is not described within this 510k submission. The hosting device decides which tools are used from Syngo Carbon Clinicals. The hosting device does not need to host all tools from the Syngo Carbon Clinicals, a desired subset of the provided tools can be used. The same can be enabled or disabled thru licenses. {5}------------------------------------------------ When preparing the radiologist's reading workflow on a dedicated workplace or workstation, Syngo Carbon Clinicals can be called to generate additional results or renderings according to the user needs using the tools available. ## 7. Intended/Indications for use: Syngo Carbon Clinicals is intended to provide advanced visualization tools to prepare and process the medical image for evaluation, manipulation and communication of clinical data that was acquired by the medical imaging modalities (for example, CT, MR, etc.) The software package is designed to support technicians and physicians in qualitative and quantitative measurements and in the analysis of clinical data that was acquired by medical imaging modalities. An interface shall enable the connection between the Syngo Carbon Clinicals software package and the interconnected software solution for viewing, manipulation, communication, and storage of medical images. ### 8. Technological Characteristics: The Syngo Carbon Clinicals plug-in provides the below listed tools. - Cinematic insight – An advanced visualization tool for cinematic rendering of anatomical structures using presets - Manual Calibration The Calibration tool is used manually calibrate non-● calibrated images to enable measurement on such images - Basic Onco Tools - Assisted Perpendicular Tool to draw perpendicular distance lines to O perform diameter measurements and thus to evaluate lesions - Lesion Quantification Tool to perform diameter measurements O (longest diameter, perpendicular diameter) and to create segmentation objects of suspect lesions in lung parenchyma with one click (semi automatically) - Lung Nodule Marker Tool used to evaluate lung parenchyma for o suspect lesions. This tool can also be used to evaluate lesions across different time points {6}------------------------------------------------ # 9. Summary of Differences between the Subject Device and the Predicate Device: The differences between the subject device in this premarket notification and the predicate device are summarized in the following comparison table: | Specification | Subject Device | Predicate Device | Comparison | Impact to Safety & Effectiveness | |----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------| | Device name and version | Syngo Carbon Clinicals (VA30A) | Syngo Carbon Space (VA30A) K230561 | New Product | NA | | Manufacturer | Siemens Healthcare GmbH | Siemens Healthcare GmbH | Same | NA | | Indications for use | Syngo Carbon Clinicals is intended to provide advanced visualization tools to prepare and process the medical image for evaluation, manipulation and communication of clinical data that was acquired by the medical imaging modalities (for example, CT, MR, etc.) The software package is designed to support technicians and physicians in qualitative and quantitative measurements and in the analysis of clinical data that was acquired by medical imaging modalities. An interface shall enable the connection between the Syngo Carbon Clinicals software package and the interconnected software solution for viewing, manipulation, communication, and storage of medical images. | Syngo Carbon Space is a software intended to display medical data and to support the review and analysis of medical images by trained medical professionals. Syngo Carbon Space "Diagnostic Workspace" is indicated for display, rendering, post- processing of medical data (mostly medical images) within healthcare institutions, for example, in the field of Radiology, Nuclear Medicine and Cardiology. | The indications for use of Syngo Carbon Clinicals is a subset of the predicate. Subject device is used in qualitative and quantitative measurements and in the analysis of clinical data which is the same as the predicate device. Note: For our equivalency comparison, the Syngo Carbon Space "Diagnostic Workspace" shall be considered since the functionalities of Syngo Carbon Space "Physician Access" is not relevant to our subject device scope. The Predicate device additionally also is used for display and rendering of medical data. | None | {7}------------------------------------------------ | Specification | Subject Device | Predicate Device | Comparison | Impact to Safety & Effectiveness | |--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------| | Contraindications | Syngo Carbon Clinicals is not indicated for mammography images for diagnosis in the U.S. Syngo Carbon Clinicals is not to be used as a sole basis for clinical decisions | Syngo Carbon Space "Diagnostic Workspace" is not intended for diagnosis of digital mammography images. Syngo Carbon Space "Diagnostic Workspace" is not intended to be used as a sole basis for clinical decisions. | Same | None | | Software architecture | Syngo Carbon Clinicals has architecture that is based on a layered pattern where the various clinical tools/functionality are decomposed into modules/common tools which provide their individual functionalities. | Syngo Carbon Space is based on a client-server architecture | A client server architecture is not used in the subject device due to the nature of the use of the subject device with the interfacing/hosting applications. | None | | Image communication | Syngo Carbon Clinicals relies on the interfacing application for Image communication. | Standard network protocols like TCP/IP and standard communication protocol including DICOM (2016a) and non-DICOM objects. Supports interfacing with HL7 (v2.5 / v2.3.1 /v2.3 / FHIR R4) | Syngo Carbon Clinicals does not have its own communication, it relies on the interfacing/hosting application for Image communication. | None | {8}------------------------------------------------ | Specification | Subject Device | Predicate Device | Comparison | Impact to Safety & Effectiveness | |-----------------------------|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------| | Image display algorithms | • Rendering Tools: Cinematic Insight | • MPR: MPR, MPR Thick, • MPR/MPR* • MIP: MIP, MIP Thin • MinIP View • VRT*: Plain VRT, Adapt VRT, • VRT Thin, Cinematic VRT (cVRT) • Fused View * • Invert Image * available in in Diagnostic Workspace only | Syngo Carbon Clinicals provides the rendering tool: Cinematic Insight which is a combination of the Automatic Organ segmentation and the cVRT technique of image display which is available in the predicate device. This feature uses a deep learning algorithm for organ segmentation (algorithm that was cleared as part of the reference device syngo.via RT Image suite (K220783). No changes have been made to this algorithm compared to the reference device The segmented organ is then rendered using the cVRT technique available in the predicate device. | This feature does not impact the safety and effectiveness of the subject device as the necessary measures are taken | {9}------------------------------------------------ | Specification | Subject Device | Predicate Device | Comparison | Impact to Safety & Effectiveness | |--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------| | Measurement, Evaluation/Interpr etation Tools | • Oncological evaluation: • Lesion Quantification • Assisted Perpendicular Tool • Lung Nodule Marker • Orthopaedic measurements: • Manual calibration | • Lesion Quantification* • Assisted Perpendicular Tool* • Automatic Organ Segmentation* • Distance (Distance line, Distance Polyline) • Angle • 2D ROI (Circle, Freehand, Polygonal, Auto Contour) * • 3D VOI (Sphere, Freehand) * • Pixel Lens • Ranges (Parallel, Radial, Radial Sliced, Curved, Spine) * • Interactive Tissue Segmentation* • Time Curve, Time ROI* • SUV Measurement* • Automatic Anatomy Labeling (rib, spine) * • Next Study/ Previous Study* * available in in Diagnostic Workspace only | Lung Nodule Marker tool is used to evaluate the lung for suspected lesions across time points. Manual calibration tool is a simple linear tool, where the user input of measurement is required for calibration of the image using a known size display image/an object of known size is available in the image | This feature does not impact the safety and effectiveness of the subject device as the necessary measures are taken | {10}------------------------------------------------ | Supported objects for display | DICOM image object display | DICOM image object display: | The supported objects for display in the subject device is a subset of the predicate device. | None | |----------------------------------|----------------------------|-----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|------| | | • CT Image | • CR Image | | | | | • DX Image | • CT Image | | | | | • CR Image | • DX Image | | | | | | • ES Image | | | | | | • GM Image | | | | | | • MG Image | | | | | | • MR Image | | | | | | • NM Image | | | | | | • PET Image | | | | | | • OP/OPT Image | | | | | | • RF Image | | | | | | • RT IMAGE | | | | | | • SM (WSI) | | | | | | • XA Image | | | | | | • US Image | | | | | | • Secondary capture objects | | | | | | DICOM non-image object display: | | | | | | • ECG | | | | | | • Encapsulated PDF | | | | | | • PR | | | | | | Non-DICOM file display: | | | | | | • Images: BMP, GIF, JPEG (JFIF), JPEG 2000, JPEG-LE, JPEG-LS, PCX, PNG, PNM, TIFF, WBMP | | | | | | • Video: FLV, H.264, H.265 | | | {11}------------------------------------------------ | Specification | Subject Device | Predicate Device | Comparison | Impact to Safety & Effectiveness | |---------------|----------------|--------------------------------------------------------------------------------------------------------------------|------------|-------------------------------------| | | | INDEO2, INDEO3, INDEO4, MPEG1, MPEG2, MPEG4, VP8, VP9, WMV1, WMV2, WMV3 Text Documents: CDA (XML), PDF | | | {12}------------------------------------------------ # ©Siemens Healthcare GmbH, 2023 | Operating system | None | Diagnostic Workspace | The interfacing/hosting application to Syngo Carbon Clinicals provides the operating system which the plug-in can use | None | |---------------------|------|---------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|------| | | | Server | | | | | | • Microsoft Windows Server 2019 | | | | | | • Windows 10 Enterprise | | | | | | • Red Hat Enterprise Linux 8.4 Client | | | | | | • Microsoft Windows 10 (Pro, Pro-Education, Enterprise) | | | | | | Physician Access Server | | | | | | • Red Hat Enterprise Linux 8.4 Client | | | | | | All operating systems that with support for the following HTML5- and JavaScript enabled browsers: | | | | | | • Google Chrome ≥ 83 (tested and recommended) | | | | | | • Microsoft Internet Explorer ≥ 11 (not recommended) | | | | | | • Microsoft Edge ≥ 83 (tested and recommended: Edge 89) | | | | | | • Mozilla Firefox ≥ 78 | | | | | | • Mozilla Firefox ESR ≥ 78 | | | | | | • Apple Safari ≥ 13 | | | {13}------------------------------------------------ | Specification | Subject Device | Predicate Device | Comparison | Impact to Safety & Effectiveness | |----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------| | | | Client – Mobile device iPadOS ≥ 14, Safari web browser | | | | Impact on Image | None Syngo Carbon Clinicals provides advanced visualization tools to prepare and process the medical images and it has no influence on the image acquisition devices | None Syngo Carbon Space is a pure viewing | Same | None | | Acquisition Devices | | and/or post-processing software and it has no influence on the image acquisition devices | | | | CAD | None | None | Same | None | | Functionalities | No automated diagnostic | No automated diagnostic | | | | | interpretation capabilities like CAD | interpretation capabilities like CAD | | | | | are included. All image data are to be interpreted by trained personnel. | are included. All image data are to be interpreted by trained personnel. | | | | Clinical | No limitation on the clinical condition | No limitation on the clinical condition | Same | None | | condition the | of the patient | of the patient | | | | device is | | | | | | intended to | | | | | | diagnose, treat, or manage | | | | | | Intended | No limitation concerning the patient | No limitation concerning the patient | Same | None | | patient population | population (e.g., age, weight, health, condition) | population (e.g., age, weight, health, condition) | | | | Site of the body the device is | No limitation concerning region of body or tissue type | No limitation concerning region of body or tissue type | Same | None | | intended to be used | | | | | | Specification | Subject Device | Predicate Device | Comparison | Impact to Safety & Effectiveness | | Intended use environment | Syngo Carbon Clinicals offers a wide range of tools from the major clinical fields, i.e. general radiology, oncology environments. | Syngo Carbon Space "Diagnostic Workspace" is used in Radiology, Nuclear Medicine and Cardiology environments (e.g., darkened/ shaded rooms). | Same | None | | Intended user(s) | Trained healthcare professionals | Trained healthcare professionals | Same | None | | Device Type | Software application | Software application | Same | None | | Cyber Security | The cybersecurity aspects for Syngo Carbon Clinicals is handled by the interfacing/hosting system. | User access control • Audit Trail • Documentation of system security information, Network traffic & Firewall control • Support of virus / malware protection • System Hardening (OS level and Network level) | Syngo Carbon Clinicals applications are running as a part of the interfacing device. The aspects for cybersecurity are assessed and provided to the interfacing application. | None | | Hardware | Hardware is not understood as part of the medical device but needs to comply with the minimum requirements as specified by Syngo | Hardware is not understood as part of the medical device but needs to comply with the minimum requirements as specified by Syngo | Same | None | | Specification | Subject Device | Predicate Device | Comparison | Impact to Safety & Effectiveness | | Graphical user interface | Not offered by Syngo Carbon Clinicals | Yes, with reduced color palette, clearer structure, and text labels on icons. Floating panels increases the user friendliness as the user can move the panels wherever they are convenient with | The subject device utilizes the GUI provided by the interfacing application | None | | Specification | Subject Device | Predicate Device | Comparison | Impact to Safety & Effectiveness | | Patient Browser | Not offered by Syngo Carbon Clinicals | Search, browse & open data for display from syngo.share core & remote DICOM nodes • Search, browse & open data for display from external XDS(-I) repository) ** • Archive functionality (upload medical data to syngo.share core for archive) • Document properties functions (metadata modification and tagging) • Correct & re-arrange functions • Restore (trigger fetch from archive) functions • Distribution, export & sharing functions • Inbox - access to medical data shared by other users ** **available in Physician Access only | NA | NA | | Specification | Subject Device | Predicate Device | Comparison | Impact to Safety & Effectiveness | | Series navigator / Document Preview | Not offered by Syngo Carbon Clinicals | Yes, with a fast overview of the displayed and not displayed data (series, images) of the loaded studies, identify not yet seen series/images*, quickly identify the relevant series/images for reading, and bring data (timepoints/series/images) into display in an efficient manner (Drag&Drop). Study / Timepoints are marked with individual colors for better identification. The Series Navigator is called Document Preview for Physician Access. * available in in Diagnostic Workspace only | NA | NA | | Findings panel | Not offered by Syngo Carbon Clinicals | Findings panel collects measurements, annotations, and graphical objects. Additionally, the user can create new findings, edit findings. It also allows creation of automatic findings | The subject device utilizes the findings panel provided by the interfacing application | None | | Specification | Subject Device | Predicate Device | Comparison | Impact to Safety & Effectiveness | | Reporting | Not offered by Syngo Carbon Clinicals | No dedicated report creation functionality supported in Syngo Carbon Space. Structured findings can be automatically transferred to external third-party reporting system via FHIR interface for creation of structured report content [e.g. (Powerscribe [by Nuance], SmartReports [by Smart Reporting)] | The subject device utiliz…