Who is the manufacturer of Syngo Carbon Space VA30A?

Siemens Healthcare GmbH filed the 510(k) submission for Syngo Carbon Space VA30A (K230561).

What is the FDA product code for Syngo Carbon Space VA30A?

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 VA30A?

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

What are the predicate devices for Syngo Carbon Space VA30A?

Syngo Carbon Space (VA20A) (K213665).

Who can help prepare an FDA 510(k) submission like Syngo Carbon Space VA30A?

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 VA30A

K230561 · Siemens Healthcare GmbH · LLZ · Mar 21, 2023 · Radiology

Device Facts

Record ID	K230561
Device Name	Syngo Carbon Space VA30A
Applicant	Siemens Healthcare GmbH
Product Code	LLZ · Radiology
Decision Date	Mar 21, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	Software as a Medical Device, 3rd-Party Reviewed

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 image management and processing system installed on standard IT hardware. It operates via a client-server architecture, where the server processes and renders data from connected modalities, and the client provides the user interface for interactive viewing and analysis. It supports DICOM and non-DICOM objects, including images, videos, and clinical documents. Used by trained medical professionals in clinical environments (e.g., Radiology, Cardiology), it enables image review, post-processing, and result distribution. The device provides tools for measurement, annotation, and segmentation (e.g., distance, angle, ROI, organ segmentation). Output is displayed on certified medical monitors to support clinical decision-making. It does not perform automated diagnostic interpretation (CAD). The system integrates with RIS and third-party reporting systems via FHIR/HL7. It benefits patients by facilitating efficient access to medical images and clinical data across the healthcare enterprise.

Clinical Evidence

No clinical studies were conducted. Substantial equivalence is supported by non-clinical performance testing, including verification and validation of software specifications and hazard analysis. Previous phantom and reader study results for the integrated Lesion Quantification Algorithm were evaluated and deemed applicable with minor design mitigations.

Technological Characteristics

Software-only medical device; client-server architecture. Supports DICOM (2016a) and non-DICOM (HL7, FHIR R4) communication. Runs on standard IT hardware (Windows/Linux). Features include MPR, MIP, MinIP, VRT, and various measurement/segmentation tools. Cybersecurity controls include user access control, audit trails, network/firewall control, and system hardening. Software level of concern: Moderate.

Indications for Use

Indicated for display, rendering, and post-processing of medical data (mostly medical images) by trained medical professionals in healthcare institutions (e.g., Radiology, Nuclear Medicine, Cardiology). Diagnostic Workspace is for display, rendering, and post-processing; Physician Access is for display and rendering. Not for diagnosis of digital mammography images, not for use as a sole basis for clinical decisions, and Physician Access is not for diagnostic use on mobile devices in the USA.

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 (VA20A) (K213665)

Reference Devices

syngo.via (Version VB40A) (K191040)
syngo.plaza (K180563)

Related Devices

K213665 — Syngo Carbon Space VA20A · Siemens Healthcare GmbH · Jun 21, 2022
K240294 — Syngo Carbon Enterprise Access (VA40A) · Siemens Healthcare GmbH · May 23, 2024
K161685 — syngo®.via protoNeo (Version VA10A) · Siemens Healthcare GmbH · Jul 11, 2016
K150843 — syngo®.via (version VB10A) · Siemens AG · Apr 24, 2015
K082269 — VISAGE PACS, VERSION 6.0/CS 3.1 · Visage Imaging, Inc. · Dec 12, 2008

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. Siemens Healthcare GmBH % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k SAINT PAUL MN 55114 March 21, 2023 Re: K230561 Trade/Device Name: Syngo Carbon Space VA30A Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: II Product Code: LLZ Dated: February 28, 2023 Received: February 28, 2023 Dear Prithul Bom: 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 {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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 mediation-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, 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) #### K230561 Device Name Syngo Carbon Space (VA30A) #### 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) | | |-------------------------------------------------|--| |-------------------------------------------------|--| X 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/0 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. Below the logo is the date "December 09, 2022". # Traditional 510(k) Summary # K230561 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 | | Fax: | +49 (9191) 18-4404 | #### 4. Device Name and Classification | Device/Trade Name: | Syngo Carbon Space (VA30A) | |------------------------|------------------------------------------------| | 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): #### Main Predicate Device: | Device/Trade Name: | Syngo Carbon Space (VA20A) | |------------------------|------------------------------------------------| | K Number | K213665 | | 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 Predicate Device 1: | Device/Trade Name: | syngo.via (Version VB40A) | |------------------------|---------------------------------------------| | K Number | K191040 | | Classification Panel: | Radiology Devices | | Classification Number: | 21 CFR 892.2050 | | Classification Name: | Picture archiving and communications system | | Device Class: | Class II | | Product Code: | LLZ | ### Reference Predicate Device 2: | Device/Trade Name: | syngo.plaza | |------------------------|---------------------------------------------| | K Number | K180563 | | Classification Panel: | Radiology Devices | | Classification Number: | 21 CFR 892.2050 | | Classification Name: | Picture archiving and communications system | | Device Class: | Class II | | Product Code: | LLZ | ### 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 {5}------------------------------------------------ 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 the 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 and the predicate device. ### 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 described in this premarket notification (Highlighted) and the following comparison table: | Specification | Subject Device | Predicate Device | Comparison | Impact to Safety & Effectiveness | |----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device name and version | Syngo Carbon Space VA30A | Syngo Carbon Space VA20A (K213665) | New version of the 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 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. | Same | NA | | Specification | Subject Device | Predicate Device | Comparison | Impact to Safety & Effectiveness | | Contraindicatio ns | 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. | 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. | Same | NA | | Software architecture | Syngo Carbon Space 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. 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) 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 & Effectiveness | | 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 * available in in Diagnostic Workspace only | Same | NA | | Specification | Subject Device | Predicate Device | Comparison | Impact to Safety & Effectiveness | | Measurement, Evaluation/Inte rpretation Tools | • Distance (Distance line, Distance Polyline) • Angle and Angle on stack* • 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/Nearline study* • Change Geometry* • Snapshot • CT Lung Change* • MR General Reading* • Alpha Blending* * Available in in Diagnostic Workspace only | • 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* * available in in Diagnostic Workspace only | The tool set in the subject device is enhanced. New basic reading tools were added to the subject device. | This differences between the predicate device and the subject device does not 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: | Same | NA | | | • CR Image | • CR Image | | | | | • 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 (JFIF), JPEG 2000, JPEG-LE, JPEG-LS, PCX, PNG, PNM, TIFF, WBMP | • 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 | • Video: FLV, H.264, H.265, INDEO2, INDEO3, INDEO4, MPEG1, MPEG2, MPEG4, VP8, VP9, WMV1, WMV2, WMV3 | | | | Specification | Subject Device…