Who is the manufacturer of Syngo Carbon Space VA20A?

Siemens Healthcare GmbH filed the 510(k) submission for Syngo Carbon Space VA20A (K213665).

What is the FDA product code for Syngo Carbon Space VA20A?

LLZ. 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 Space VA20A?

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

Who can help prepare an FDA 510(k) submission like Syngo Carbon Space VA20A?

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.

Syngo Carbon Space VA20A

K213665 · Siemens Healthcare GmbH · LLZ · Jun 21, 2022 · Radiology

Device Facts

Record ID	K213665
Device Name	Syngo Carbon Space VA20A
Applicant	Siemens Healthcare GmbH
Product Code	LLZ · Radiology
Decision Date	Jun 21, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	Software as a Medical Device

Intended Use

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.

Device Story

Syngo Carbon Space is a software-only medical device for viewing, post-processing, and distributing medical images and documents. It operates via a client-server architecture, with a 'Diagnostic Workspace' (thick client) for radiologists and a 'Physician Access' (web client) for enterprise-wide viewing. Inputs include DICOM and non-DICOM medical images, multimedia, and clinical documents. The server handles image processing and temporary storage, while the client provides the user interface for interactive viewing, measurement, and annotation. Healthcare providers use the output to support clinical review and analysis. The device integrates with RIS and third-party reporting systems via FHIR/HL7. It does not perform automated diagnostic interpretation (CAD). Benefits include improved access to patient data and streamlined radiological workflows.

Clinical Evidence

No clinical studies were conducted. Performance was established through non-clinical verification and validation, including phantom and reader studies for the lesion segmentation algorithm, which were found acceptable.

Technological Characteristics

Software-only application; client-server architecture. Supports DICOM (2016a), HL7, and FHIR R4. Runs on Windows 10/Server 2019 or RHEL 8.4. Includes non-deep learning algorithms for lesion quantification, segmentation, and image processing (MPR, MIP, VRT). Cybersecurity includes user access control, audit trails, and OS/network-level hardening per IASE DISA standards.

Indications for Use

Indicated for trained medical professionals to display, render, and post-process medical data (primarily images) within healthcare institutions, including Radiology, Nuclear Medicine, and Cardiology. Not intended for digital mammography diagnosis or as the 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.via (VB40A) (K191040)

Related Devices

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K111079 — SYNGO.VIA WEB VIEWER · Siemens AG Medical Solutions · May 13, 2011
K082269 — VISAGE PACS, VERSION 6.0/CS 3.1 · Visage Imaging, Inc. · Dec 12, 2008
K161685 — syngo®.via protoNeo (Version VA10A) · Siemens Healthcare GmbH · Jul 11, 2016

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. Siemens Healthcare GmbH % Vijay Ramadas Regulatory Affairs Manager Siemensstr. 1 Forchheim. Baveria 91301 GERMANY June 21, 2022 Re: K213665 Trade/Device Name: Syngo Carbon Space VA20A Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: May 16, 2022 Received: May 19, 2022 Dear Vijay 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 (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about 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. Ph.D. Assistant Director Imaging Software 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 {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K213665 Device Name Syngo Carbon Space VA20A #### Indications for Use (Describe) 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. Syngo Carbon Space "Physician Access" is indicated for display and rendering of medical data within healthcare institutions. | Type of Use (Select one or both, as applicable) | | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------| | <div style="display: inline-block; vertical-align: middle;"> <img alt="Checked" src="checked.png" style="width: 15px; height: 15px; vertical-align: middle;"/> </div> 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}------------------------------------------------ K213665 Image /page/3/Picture/1 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a graphic of orange dots. # 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. 1 91301 Forchheim Germany E-mail: vijay.ramadas(@siemens-healthineers.com Telephone: +49 (172) 4324369 Fax: +49 (9191) 18-4404 #### 4. Device Name and Classification | Device/Trade Name: | Syngo Carbon Space (VA20A) | |------------------------|------------------------------------------------| | Classification Panel: | Radiology | | Classification Number: | 21 CFR 892.2050 | | Classification Name: | Medical Image Management and Processing System | | Device Class: | Class II | | Product Code: | LLZ | #### 5. Legally Marketed Predicate Device: | Device/Trade Name: | syngo.via (VB40A) | |-----------------------|----------------------------------------------------------------------------------| | 510(k) Clearance: | K191040 | | Clearance Date: | May 16, 2019 | | Classification Name: | Picture Archiving and Communications System | | Classification Panel: | Radiology | | CFR Section: | 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. | {4}------------------------------------------------ ### 6. Device Description: Syngo Carbon Space is a software only medical device which is intended to be installed on recommended common IT Hardware. The hardware is not seen as part of the medical device. Syngo Carbon Space is intended to support reviews and analysis of medical images by trained medical practitioners. The software is used in Radiology for reading images and throughout the healthcare institutions for image & result distribution. Syngo Carbon Space is a medical device, provided in two variants/options. - Diagnostic Workspace (Fat/Thick Client) - - -Physician Access (Thin/Web Client) In any scenario, both the options can be installed/run on the same machine and be used simultaneously. Syngo Carbon Space Diagnostic Workspace provides a reading workspace for Radiology that supports display of medical image data & documents and connects intelligent work tools (diagnostic and non-diagnostic software elements) to enable easy access to the data needed, easy access to external tools and creation of actionable results. Syngo Carbon Space Physician Access provides a zero-footprint web application for enterprise-wide viewing of DICOM, non-DICOM, multimedia data and clinical documents to facilitate image and result distribution in the healthcare institution. Since Syngo Carbon Space is a software only product, shelf-life is not applicable because of low likelihood of time-dependent product degradation. Hence performance data is not needed to establish maintenance of device performance characteristics over the shelf-life period Syngo Carbon Space is a software only medical device, which is delivered by download only option to be installed on common IT hardware. This hardware must fulfil the defined requirements. Any hardware platform that complies to the specified minimum hardware and software requirements and with successful installation verification and validation activities can be supported. The hardware itself is not seen as part of the medical device and therefore not in the scope of this 510(k) submission. Syngo Carbon Space provides tools and features to cover the radiological tasks reading images and support reporting through third party tools. It supports DICOM and Non-DICOM objects. In a comprehensive imaging suite, Syngo Carbon Space interoperates with a Radiology Information System (RIS) to enable customer specific workflows. Syngo Carbon Space is based on a client-server architecture. The server processes and renders the data from the connected modalities. The server provides central services including image processing and temporary storage. The client provides the user interface for interactive image viewing and processing and can be installed and started on each workplace that has a network connection to the server. Syngo Carbon Space supports various monitor setups and can be adapted to a range of image types by connecting different monitor types. The subject device and the predicate device share fundamental scientific technology. This device description holds true for the subject device, Syngo Carbon {5}------------------------------------------------ Space software version VA20A, as well as the predicate device, syngo.via, software version VB40A. ### 7. Intended Use: 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. ### 8. Indications for Use: 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, postprocessing of medical data (mostly medical images) within healthcare institutions, for example, in the field of Radiology, Nuclear Medicine and Cardiology. Syngo Carbon Space "Physician Access" is indicated for display and rendering of medical data within healthcare institutions. {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 (K number) | Syngo Carbon Space VA20A | syngo.via VB40A (K191040) | New product | NA | | Manufacturer | Siemens Healthcare GmbH | Siemens Healthcare GmbH | Same | NA | | Indications for use | 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. Syngo Carbon Space "Physician Access" is indicated for display and rendering of medical data within healthcare institutions. | syngo.via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a stand-alone device or together with a variety of cleared and unmodified syngo based software options. syngo.via supports interpretation and evaluation of examinations within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments. | Syngo Carbon Space is a device available in two options, Diagnostic - Workspace (Thick Client) Physician Access (Web Client) with same intended use and Indications to use. Additionally, Syngo Carbon Space displays Non-DICOM Artifacts | Display of Non- DICOM artifacts in the subject device doesn't impact the safety and effectiveness of the device, as necessary measures have been taken | {7}------------------------------------------------ | Specification | Subject Device | Predicate Device | Comparison | Impact to Safety & Effectiveness | |--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contraindications | 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. Syngo Carbon Space "Physician Access" is not intended for diagnosis of digital mammography images. Syngo Carbon Space "Physician Access" is not intended to be used for diagnostic purpose on mobile devices in the United States of America (USA). Syngo Carbon Space "Physician Access" is not intended to be used as a sole basis for clinical decisions. | The system is not intended for the displaying of digital mammography images for diagnosis in the U.S. | The subject device includes additional contraindication statements which acts as a caution to the user about the usage of the device while making a clinical decision from medical images or clinical documents. | The difference in 'contra-Indications' between the predicate device and the subject device doesn't impact the safety and effectiveness of the subject device as necessary measures have been taken | | Software architecture | Syngo Carbon Space is based on a client-server architecture | syngo.via is based on a client-server architecture | Same | NA | {8}------------------------------------------------ | Specification | Subject Device | Predicate Device | Comparison | Impact to Safety & Effectiveness | |----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 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). | Standard network protocols like TCP/IP and standard communication protocol including DICOM (2016a) objects. Allows interfacing with HL7 (v2.5 / v2.3.1 / v2.3). | Syngo Carbon Space additionally allows communication with non-DICOM artefacts and FHIR interface | The difference in image communication between the predicate device and the subject device doesn't impact the safety and effectiveness of the subject device as necessary measures have been taken | | Image display algorithms | MPR: MPR, MPR Thick, MPR/MPR* MIP: MIP, MIP Thin MinIP View VRT*: Plain VRT, Adapt VRT, VRT Thin, Cinematic VRT Fused View * Invert Image * available in in Diagnostic Workspace only | MPR: MPR, MPR Thick, MPR/MPR MIP: MIP, MIP Thin MinIP View VRT: Plain VRT, Adapt VRT, VRT Thin, Cinematic VRT Fused View Invert Image | Same | NA | | Specification | Subject Device | Predicate Device | Comparison | Impact to Safety & Effectiveness | | Measurement, Evaluation/Inte rpretation Tools | • 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) * • Lesion Quantification * • Assisted Perpendicular Tool* • Automatic Organ Segmentation* • Interactive Tissue Segmentation* • Time Curve, Time ROI* • SUV Measurement* • Automatic Anatomy Labeling (rib, spine) * • Next Study/ Previous Study* • Time Curve, Time ROI* * available in in Diagnostic Workspace only | • Distance (Distance Line, Distance Polyline) • Angle • 2D ROI (Circle, Freehand, Polygonal) • 3D VOI (Sphere, Freehand) • Pixel Lens • Ranges (Parallel, Radial, Radial Sliced, Curved, Spine, Vascular) • Assisted Perpendicular Tool • Automatic Organ Segmentation • Interactive Tissue Segmentation • Time Curve, Time ROI • Define Vessel • SUV Measurement • Automatic Anatomy Labeling (rib, spine) • Basic Onco Tool (Assisted Perpendicular Tool) • Change Visualization • Next Study/ Previous Study | The evaluation/interpretation functionalities in the subject device are enhanced. Lesion Quantification Enables the user to perform diameter measurements and to create segmentation objects of suspect lesions in lung parenchyma. This is a non-Deep learning algorithm | This differences between the predicate device and the subject device doesn't impact the safety and effectiveness of the subject device as the necessary measures taken | | Supported objects for display | DICOM image object display: | DICOM image object display: | The subject device supports additional image object types for display: | This difference in supported DICOM modality and Non- DICOM object types between the predicate device and the subject device doesn't impact the safety and effectiveness of the subject device as necessary measures have been taken | | | DICOM image object display: • CR Image • CT 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 image object display: • CR Image • CT Image • DX Image • MG Image • MR Image • NM Image • PET Image • XA Image • US Image • Secondary capture objects | DICOM image object display: • ES Image • GM Image • OP/OPT Image • SM (WSI) 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, INDEO2, INDEO3, INDEO4, MPEG1, MPEG2, MPEG4, VP8, VP9, | | | | 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, INDEO2, INDEO3, INDEO4, MPEG1, MPEG2, MPEG4 | | | | | Specification | Subject Device | Predicate Device | Comparison | Impact to Safety & Effectiveness | | | VP8, VP9, WMV1, WMV2, WMV3 • Text Documents: CDA (XML), PDF | | WMV1, WMV2, WMV3 • Text Documents: CDA (XML), PDF | | | Operating system | Diagnostic Workspace | Windows client | In the subject device | This Operating | | | Server | | client supports Microsoft | System difference | | | Microsoft Windows Server 2019 Windows 10 IoT Red Hat Enterprise Linux 8.4 | Microsoft Windows 7 SP1 Microsoft Windows 8 (8.1 Pro, 8.1 Enterprise) Microsoft Windows 10 (Home, Pro, Education, Enterprise) | Windows 10 Operating system and Server supports Microsoft Windows Server 2019, Windows 10 IoT, and Red Hat Enterprise Linux 8.4 compared to the predicate device. | between the | | | Client | | | predicate device and | | | Microsoft Windows 10 (Pro, Pro-Education, Enterprise) | Windows Server | | the subject device | | | | Microsoft Windows Server 2008 R2 Microsoft Windows Server 2012 R2 Microsoft Windows Server 2016 | | doesn't impact the | | | Physician Access | | | safety and | | | Server | | | effectiveness of the | | | Red Hat Enterprise Linux 8.4 | | | subject device as | | | Client - Workplace All operating systems that with support for the following HTML5- and JavaScript enabled browsers: | | | necessary measures have been taken | | | 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 | | | | | | Client - Mobile device iPadOS > 14, Safari web browser | | | | | Specification | Subject Device | Predicate Device | Comparison | Impact to Safety & Effectiveness | | Impact on Image Acquisition Devices | None Syngo Carbon Space is a pure viewing and/or post-processing software and it has no influence on the image acquisition devices. | None syngo.via is a pure viewing and/or post-processing software and it has no influence on the image acquisition devices. | Same | NA | | CAD Functionalities | None No automated diagnostic interpretation capabilities like CAD are included. All image data are to be interpreted by trained personnel. | None No automated diagnostic interpretation capabilities like CAD are included. All image data are to be interpreted by trained personnel. | Same | NA | | Clinical condition the device is intended to diagnose, treat, or manage | No limitation on the clinical condition of the patient. | No limitation on the clinical condition of the patient. | Same | NA | | Intended patient population | No limitation concerning the patient population (e.g., age, weight, health, condition) | No limitation concerning the patient population (e.g., age, weight, health, condition)…