Syngo Carbon Enterprise Access (VA40A)

K240294 · Siemens Healthcare GmbH · LLZ · May 23, 2024 · Radiology

Device Facts

• Record ID: K240294
• Device Name: Syngo Carbon Enterprise Access (VA40A)
• Applicant: Siemens Healthcare GmbH
• Product Code: LLZ · Radiology
• Decision Date: May 23, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Syngo Carbon Enterprise Access is indicated for display and rendering of medical data within healthcare institutions.

Device Story

Syngo Carbon Enterprise Access is a web-based software application for enterprise-wide viewing of DICOM, non-DICOM, multimedia data, and clinical documents. Installed on standard IT hardware, it provides standardized interfaces to connect to medical devices without controlling or altering their functions. Used in departmental environments within healthcare institutions by trained medical professionals, the device facilitates image and result distribution. It supports viewing of various image types (CT, MR, PET, XA, US, etc.) and non-image objects (ECG, PDF). The system features a client-server architecture; users access data via HTML5/JavaScript-enabled browsers. The device provides tools for image manipulation (zoom, pan, windowing, flip, scroll) and measurement/annotation (distance, angle, ellipse, polygon). It does not perform automated diagnostic interpretation (CAD). By providing efficient access to medical images and patient history, the device supports clinical review and decision-making, benefiting patients through improved access to diagnostic information.

Clinical Evidence

No clinical studies were conducted. Performance was established through non-clinical verification and validation testing, including software testing, risk analysis, and cybersecurity assessment. Testing confirmed that all software specifications met acceptance criteria.

Technological Characteristics

Software-only medical device; client-server architecture. Connectivity via standard network protocols (TCP/IP, DICOM 2016a, HL7, FHIR R4). Supported by HTML5/JavaScript-enabled browsers (Chrome, Edge, Firefox, Safari). Cybersecurity controls include user access control, audit trails, firewall control, malware protection, and system hardening. Conforms to ISO 14971, IEC 62304, IEC 82304-1, and IEC 62366-1. Moderate level of concern.

Indications for Use

Indicated for display and rendering of medical data within healthcare institutions by trained medical professionals. Not intended for diagnosis of digital mammography images or digital pathology reading. Not intended for diagnostic use on mobile devices in the USA. Not intended 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)

Submission Summary (Full Text)

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Siemens Healthcare GmbH Vijay Ramadas Regulatory Affairs Manager Siemensstraße 3 FORCHHEIM, BAYERN 91301 GERMANY

May 23, 2024

Re: K240294

Trade/Device Name: Syngo Carbon Enterprise Access (VA40A) Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: April 15, 2024 Received: April 15, 2024

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 (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).

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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 QS 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 ([e-mail]) or phone [phone] 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

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# Indications for Use

Submission Number (if known)

K240294

Device Name

Syngo Carbon Enterprise Access (VA40A)

Indications for Use (Describe)

Syngo Carbon Enterprise Access is indicated for display and rendering of medical data within healthcare institutions

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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K240294

Image /page/3/Picture/1 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a cluster of orange dots.

January 30, 2024

# 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: | [e-mail] |
|------------|----------------------------------------|
| Telephone: | [phone] |
| Fax: | [phone] |

#### 4. Device Name and Classification

| Device/Trade Name: | Syngo Carbon Enterprise Access (VA40A) |
|------------------------|------------------------------------------------|
| 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 |

#### 5. Predicate Device(s):

| 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 |

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### 6. Device Description:

Syngo Carbon Enterprise Access 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 Enterprise Access is intended to be used in clinical image and result distribution for diagnostic purposes by trained medical professionals and provides standardized generic interfaces to connect to medical devices without controlling or altering their functions.

Syngo Carbon Enterprise Access provides an enterprise-wide web application for viewing DICOM, non-DICOM, multimedia data and clinical documents to facilitate image and result distribution.

### 7. Intended/Indications for use:

Syngo Carbon Enterprise Access is indicated for display and rendering of medical data within healthcare institutions.

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### 8. 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:

The predicate device is available in two variants;

- Syngo Carbon Space Diagnostic Workspace ।
- Syngo Carbon Space Physician Access (web component this is the predicate for the subject device) -

For readability and comparison purpose, the non-relevant items from the predicate of Syngo Carbon Space Diagnostic Workspace) are GREYED OUT and the relevant contents are retained

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| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &<br>Effectiveness |
|-------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device name<br>and version | Syngo Carbon Enterprise Access<br>VA40A | Syngo Carbon Space VA30A<br>(K230561) | New version of the<br>product | NA |
| Manufacturer | Siemens Healthcare GmbH | Siemens Healthcare GmbH | Same | NA |
| Indications for<br>use | Syngo Carbon Enterprise Access is<br>indicated for display and rendering of<br>medical data within healthcare<br>institutions. | Syngo Carbon Space is a software<br>intended to display medical data and to<br>support the review and analysis of<br>medical images by trained medical<br>professionals.<br><br>Syngo Carbon Space "Diagnostic<br>Workspace" is indicated for display,<br>rendering, post-processing of medical<br>data (mostly medical images) within<br>healthcare institutions, for example, in<br>the field of Radiology, Nuclear<br>Medicine and Cardiology.<br><br>Syngo Carbon Space "Physician<br>Access" is indicated for display and<br>rendering of medical data within<br>healthcare institutions. | Same | NA |
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety & Effectiveness |
| Contraindications | Syngo Carbon Enterprise Access is not intended for the diagnosis of digital mammography images and digital pathology reading.<br><br>Syngo Carbon Enterprise Access is not intended to be used for diagnostic purpose on mobile devices in the United States of America (USA).<br><br>Syngo Carbon Enterprise Access is not intended to be used as a sole basis for clinical decisions. | Syngo Carbon Space "Diagnostic Workspace" is not intended for diagnosis of digital mammography images.<br><br>Syngo Carbon Space "Diagnostic Workspace" is not intended to be used as a sole basis for clinical decisions.<br><br>Syngo Carbon Space "Physician Access" is not intended for diagnosis of digital mammography images.<br><br>Syngo Carbon Space "Physician Access" is not intended to be used for diagnostic purpose on mobile devices in the United States of America (USA).<br><br>Syngo Carbon Space "Physician Access" is not intended to be used as a sole basis for clinical decisions. | Same | NA |
| Software architecture | Syngo Carbon Enterprise Access is based on a client-server architecture | Syngo Carbon Space is based on a client-server architecture | Same | NA |
| Image communication | Standard network protocols like TCP/IP and standard communication protocol including DICOM (2016a) and non-DICOM objects. | 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) | Same | NA |
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &<br>Effectiveness |
| Image display<br>algorithms | MPR: MPR MIP: MIP, MinIP View AVG MED Invert Image | MPR: MPR, MPR Thick,<br>MPR/MPR* MIP: MIP, MIP Thin MinIP View VRT*: Plain VRT, Adapt VRT,<br>VRT Thin, Cinematic VRT Fused View * Invert Image * available in in Diagnostic<br>Workspace only | The additional AVG<br>and MED are non<br>AI/ML Algorithms | This differences<br>between the<br>predicate device and<br>the subject device<br>doesn't impact the<br>safety and<br>effectiveness of the<br>subject device as the<br>necessary measures<br>taken |
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &<br>Effectiveness |
| Measurement,<br>Evaluation/Inte<br>rpretation<br>Tools | • Distance (Distance line)<br>• Pixel Lens<br>• Angle<br>• Ellipse Annotation<br>• Polygon<br>• Freehand<br>• Capture | • Distance (Distance line, Distance<br>Polyline)<br>• Angle and Angle on stack*<br>• 2D ROI (Circle, Freehand,<br>Polygonal, Auto Contour) *<br>• 3D VOI (Sphere, Freehand) *<br>• Pixel Lens<br>• Ranges (Parallel, Radial, Radial<br>Sliced, Curved, Spine) *<br>• Lesion Quantification*<br>• Assisted Perpendicular Tool*<br>• Automatic Organ Segmentation*<br>• Interactive Tissue Segmentation*<br>• Time Curve, Time ROI*<br>• SUV Measurement*<br>• Automatic Anatomy Labeling<br>(rib, spine) *<br>• Next Study/Previous<br>Study/Nearline study*<br>• Change Geometry*<br>• Snapshot<br>• CT Lung Change*<br>• MR General Reading*<br>• Alpha Blending*<br>* Available in in Diagnostic<br>Workspace only | The tool set in the<br>subject device is<br>enhanced. | This differences<br>between the<br>predicate device and<br>the subject device<br>doesn't impact the<br>safety and<br>effectiveness of the<br>subject device as the<br>necessary measures<br>taken |
| Supported<br>objects<br>for display | DICOM image object display: | DICOM image object display: | Same | NA |
| | • CR Image | • CR Image | Same | NA |
| | • CT Image | • CT Image | | |
| | • DX Image | • DX Image | | |
| | • ES Image | • ES Image | | |
| | • GM Image | • GM Image | | |
| | • MG Image | • MG Image | | |
| | • MR Image | • MR Image | | |
| | • NM Image | • NM Image | | |
| | • PET Image | • PET Image | | |
| | • OP/OPT Image | • OP/OPT Image | | |
| | • RF Image | • RF Image | | |
| | • RT IMAGE | • RT IMAGE | | |
| | • SM (WSI) | • SM (WSI) | | |
| | • XA Image | • XA Image | | |
| | • US Image | • US Image | | |
| | • Secondary capture objects | • Secondary capture objects | | |
| | DICOM non-image object display: | DICOM non-image object display: | | |
| | • ECG | • ECG | | |
| | • Encapsulated PDF | • Encapsulated PDF | | |
| | • PR | • PR | | |
| | Non-DICOM file display: | Non-DICOM file display: | | |
| | • Images: BMP, GIF, JPEG<br>(JFIF), JPEG 2000, JPEG-LE,<br>JPEG-LS, PCX, PNG, PNM,<br>TIFF, WBMP | • Images: BMP, GIF, JPEG<br>(JFIF), JPEG 2000, JPEG-LE,<br>JPEG-LS, PCX, PNG, PNM,<br>TIFF, WBMP | | |
| | • Video: FLV, H.264, H.265,<br>INDEO2, INDEO3, INDEO4,<br>MPEG1, MPEG2, MPEG4. | • Video: FLV, H.264, H.265,<br>INDEO2, INDEO3, INDEO4,<br>MPEG1, MPEG2, MPEG4. | | |
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &<br>Effectiveness |
| | VP8, VP9, WMV1, WMV2,<br>WMV3<br>Text Documents: CDA (XML), PDF | VP8, VP9, WMV1, WMV2,<br>WMV3<br>• Text Documents: CDA (XML), PDF | | |
| Operating<br>system | Server | Diagnostic Workspace | The operating system | This Operating<br>System and browser |
| | Server Red Hat Enterprise Linux 9.x Client All operating systems that with<br>support for the following HTML5-<br>and JavaScript enabled browsers: Google Chrome ≥ 90 Microsoft Edge ≥ 90 Mozilla Firefox ≥ 91 Mozilla Firefox ESR ≥ 91 Apple Safari ≥ 15 Mobile device iPadOS ≥ 16 Apple Safari web browser >= 15 | Server Microsoft Windows Server 2019 Windows 10 Enterprise Red Hat Enterprise Linux 8.4 Client Microsoft Windows 10<br>(Pro, Pro-Education, Enterprise) Microsoft Windows 11<br>(Pro, Pro-Education,<br>Enterprise) Physician Access Server Red Hat Enterprise Linux 8.4 Client All operating systems that with<br>support for the following HTML5-<br>and JavaScript enabled browsers: Google Chrome ≥ 90<br>(tested and recommended<br>Chrome 100) Microsoft Edge ≥ 90<br>(tested and recommended:<br>Edge 100) Mozilla Firefox ≥ 91 Mozilla Firefox ESR ≥ 91 Apple Safari ≥ 14 | for Linux, iOS and<br>Safari browser version<br>is updated | version difference<br>between the<br>predicate device and<br>the subject device<br>doesn't impact the<br>safety and<br>effectiveness of the<br>subject device as<br>necessary measures<br>have been taken |
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety & Effectiveness |
| Impact on Image Acquisition Devices | None<br>Syngo Carbon Enterprise Access is a pure viewing software and it has no influence on the image acquisition devices. | Client – Mobile device<br>iPadOS ≥ 14, Safari web browser<br>None<br>Syngo Carbon Space is a pure viewing and/or post-processing software and it has no influence on the image acquisition devices. | Same | NA |
| CAD Functionalities | None<br>No automated diagnostic interpretation capabilities like CAD are included. All image data are to be interpreted by trained personnel. | None<br>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) | Same | NA |
| Site of the body the device is intended to be used | No limitation concerning region of body or tissue type | No limitation concerning region of body or tissue type | Same | NA |
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &<br>Effectiveness |
| Intended use<br>environment | Syngo Carbon Enterprise Access is<br>used in departmental environments<br>within healthcare institutions.<br>For reading images certified monitors<br>are required (e.g., medical diagnostic<br>displays). | Syngo Carbon Space "Diagnostic<br>Workspace" is used in Radiology,<br>Nuclear Medicine and Cardiology<br>environments (e.g., darkened/ shaded<br>rooms).<br>Syngo Carbon Space "Physician<br>Access" is used in departmental<br>environments within healthcare<br>institutions.<br>For reading images certified monitors<br>are required (e.g., medical diagnostic<br>displays).…