RadUnity (Version 1.0.0)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. RadUnity Corp. % James Luker Sr. Regulatory Consultant Innolitics 1101 West 34th St #220 Austin, Texas 78705 Re: K242810 November 26, 2024 Trade/Device Name: RadUnity (Version 1.0.0) Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: September 15, 2024 Received: September 18, 2024 Dear James Luker: 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. {1}------------------------------------------------ Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality 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. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-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-regulatory {2}------------------------------------------------ assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Jessica Lamb Jessica Lamb, PhD 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 {3}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K242810 Device Name RadUnity (Version 1.0.0) #### Indications for Use (Describe) RadUnity receives medical images from CT imaging acquisition devices adhering to the DICOM protocol for image transfer. RadUnity performs imagement and digital image processing (centralized specification and reformating) on the data. The processed images are transferred using the DICOM protocol to other devices supporting this standard protocol. RadUnity is indicated for use by qualified radiology professionals and specialists. RadUnity is not intended for primary diagnostic review. RadUnity is not intended for mammographic image review or interpretation. | 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." {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the text "RadUnity" in a bold, sans-serif font. Below the text is a graphic that appears to be a stylized representation of a connection or link. On the left, there are three wavy lines that converge into a rounded square shape, and on the right, there are three straight lines extending from the same square shape. (Per 21 CFR 807.92) # 1. CONTACT INFORMATION | Company Name | RadUnity Corp. | |------------------------------|-------------------------------------| | Address | 2127 Regent Street Madison WI 53726 | | Phone Number | 716 560 7751 | | Fax Number | N/A | | Company Representative | Timothy Szczykutowicz | | Email | tim@radunity.com | | Primary Contact | Timothy Szczykutowicz | | Primary Contact Phone Number | 716 560 7751 | | Primary Contact Email | tim@radunity.com | | Date Summary Prepared | August 8, 2024 | # 2. DEVICE INFORMATION | Trade Name | RadUnity (Version 1.0.0) | |-------------------|------------------------------------------------| | Common Name | Radiologic image processing system | | Product Code | LLZ | | Regulation Number | 21 CFR 892.2050 | | Regulation Name | Medical image management and processing system | | Class | 2 | | Review Panel | Radiology | | 510(k) Summary | |----------------| | Page 1 of 19 | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "RadUnity" in bold, black font. Below the word is a graphic of three horizontal lines. The lines on the left side of the image are wavy, and they connect to a black square in the middle of the image. The lines on the right side of the image are straight. (Per 21 CFR 807.92) # 3. PRIMARY PREDICATE DEVICE INFORMATION | Predicate Device Name | AquariusAPS Server | |------------------------------|------------------------------------------------| | Predicate Device K<br>Number | K061214 | | Product Code | LLZ | | Regulation Number | 21 CFR 892.2050 | | Regulation Name | Picture Archiving and Communications<br>System | | Class | 2 | | Review Panel | Radiology | ## 4. SECONDARY PREDICATE DEVICE INFORMATION | Predicate Device Name | Centricity PACS-IW with Universal Viewer | |------------------------------|------------------------------------------------| | Predicate Device K<br>Number | K123174 | | Product Code | LLZ | | Regulation Number | 21 CFR 892.2050 | | Regulation Name | Picture Archiving and Communications<br>System | | Class | 2 | | Review Panel | Radiology | ## 5. DEVICE DESCRIPTION RadUnity is stand-alone software device (SaMD) which allows centralized specification, management, standardization, and networking of CT images. RadUnity's software ingests DICOM CT image data and reformats them according to predefined user preferences. | 510(k) Summary | | |----------------|--| | Page 2 of 19 | | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the word "RadUnity" in bold, black font. Below the word is a black shape that looks like a rounded square with three horizontal lines extending from the right side. On the left side of the shape are three wavy lines that connect to the shape. #### (Per 21 CFR 807.92) Radunity processes industry standard DICOM imaging studies. Currently, the RadUnity solution only processes computed tomography (CT) images. The data may flow into the system from PACS, a post-processing system, or any DICOM node (e.g., directly from a modality unit). The data is transferred for image processing and standardization. The data is then routed to user defined DICOM destinations and output in DICOM format. RadUnity is fundamentally a workflow management system which performs image processing and standardization which allows the clinical user to view the CT images with consistent formatting. RadUnity provides the user with the ability to duplicate current clinical workflow steps required to generate images for qualified clinician interpretation that may involve automatic or manual steps. The RadUnity solution requires manual user interaction to generate and route images to DICOM destinations for qualified clinician interpretation. The input DICOM images needed for RadUnity are referred to as "source volumes". These source volumes are commonplace in the radiology community today (e.g., lung or bone reconstructions) and contain the needed information to create soft tissue and other thicker slice and lower resolution image volumes. ## 6. SUBJECT DEVICE INTENDED USE/INDICATIONS FOR USE RadUnity receives medical images from CT imaging acquisition devices adhering to the DICOM protocol for image transfer. RadUnity performs image management and digital image processing (centralized specification and reformatting) on the data. The processed images are transferred using the DICOM protocol to other devices supporting this standard protocol. RadUnity is indicated for use by qualified radiology professionals and specialists. RadUnity is not intended for primary diagnostic review. RadUnity is not intended for mammographic image review or interpretation. ## 7. SUBJECT DEVICE CONTRAINDICATIONS FOR USE RadUnity has no specific contraindications. However, the following Precautions are applicable to RadUnity: - The RadUnity Graphic User Interface (GUI) is not intended for primary diagnostic review. - RadUnity is not intended for mammographic image review or interpretation, ● - RadUnity should not not be used outside of its stated Intended Use/Indications for Use, ● 510(k) SummaryPage 3 of 19 {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the word "RadUnity" in bold, black font. Below the word is a symbol that consists of three wavy lines on the left, connected to a black square in the middle, and three straight lines on the right. The symbol is centered below the word. #### (Per 21 CFR 807.92) - Users should not attempt to circumvent RadUnity cybersecurity controls, ● - RadUnity should not be used for real-time imaging applications. - . RadUnity should not be used Use for non-CT imaging datasets, - . Source volume images must be axial CT images in Hounsfield units (i.e., no volume renderings, dual-energy material basis images, quantitative perfusion maps, sagittal/coronal/oblique plane images, MIP images, minIP images or any other images not containing axial CT image data in units of Hounsfield unit). #### 8. SUBSTANTIAL EQUIVALENCE DISCUSSION #### 8.1.Primary Predicate Device Intended Use/Indications for Use The AquariusAPS server receives medical images from medical imaging acquisition devices adhering to the DICOM protocol for image transfer such as EBT, CT, MRI, and other volumetric or planar medical imaging modalities, and performs digital image processing to derive certain information or new images from these image sets. The information or new images thus derived is transmitted using the DICOM protocol to other devices supporting this standard protocol. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA. #### 8.2.Secondary Predicate Device Intended Use/Indications for Use Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Megapixel resolution and meet other technical specifications reviewed and accepted by the FDA. Typical users of this system are trained professionals, including but not limited to radiologists, | 510(k) Summary | |----------------| | Page 4 of 19 | {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the word "RadUnity" in a bold, sans-serif font. Below the word, there is a graphic that appears to be a stylized representation of a connection or signal. The graphic consists of three wavy lines on the left, connected to a rounded square in the middle, which then connects to three straight lines on the right. (Per 21 CFR 807.92) physicians, nurses, medical technicians, and assistants. #### 8.3.Intended Use/Indications for Use Equivalence Discussion | Subject Device | Primary Predicate Device | Secondary Predicate Device | Equivalence Discussion | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | RadUnity (Version 1.0.0)<br><br>RadUnity receives medical images from CT imaging acquisition devices adhering to the DICOM protocol for image transfer. RadUnity performs image management and digital image processing (centralized specification and reformatting) on the data. The processed images are transferred using the DICOM protocol to other devices supporting this standard protocol. RadUnity is indicated for use by qualified radiology professionals and specialists. RadUnity is not intended for primary diagnostic review. RadUnity is not intended for mammographic image review or interpretation. | Terarecon AquariusAPS Server (K061214)<br><br>The AquariusAPS server receives medical images from medical imaging acquisition devices adhering to the DICOM protocol for image transfer such as EBT, CT, MRI, and other volumetric or planar medical imaging modalities, and performs digital image processing to derive certain information or new images from these image sets. The information or new images thus derived is transmitted using the DICOM protocol to other devices supporting this standard protocol. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed | GE Centricity PACS-IW (K123174)<br><br>Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Megapixel resolution and meet other technical specifications reviewed and accepted by the FDA. Typical users of this system are trained | Equivalent to Primary Predicate Terarecon AquariusAPS Server (K061214)-<br>The subject RadUnity device and the primary predicate device AquariusAPS server are intended to receive, process and transfer DICOM CT images using the DICOM protocol. The AquariusAPS server is intended to receive, process, manage and transfer DICOM images from additional imaging modalities such as EBT, CT, MRI and other volumetric or planar medical imaging modalities. RadUnity is not intended for use for these additional DICOM imaging modalities.<br>Additionally, RadUnity does not process raw sinogram or projection data from CT images which is equivalent to the AquariusAPS server<br>RadUnity functions in an equivalent manner in terms of safety and effectiveness to AquariusAPS server in the receipt, processing, management and transferring of DICOM CT images. | | and accepted by FDA. | but not limited to radiologists, physicians, nurses, medical technicians, and assistants. | AquariusAPS server are intended to provide pre-processing of images and to remove the need for an image review system to perform these activities. This is a primary area of equivalence to the AquariusAPS server primary predicate device. RadUnity includes the ability to view images in order to facilitate the processing functionality but is not intended to be used as the primary review software. The PACS system which receives the processed images from RadUnity is intended for the diagnostic review aspect. This is equivalent to the AquariusAPS server in terms of functionality, safety and effectiveness. RadUnity is not intended for mammographic image review or interpretation. The AquariusAPS server is intended for interpretation of mammographic images under specific circumstances. RadUnity's clinical workflow does not include review/interpretation of mammographic images. Therefore, the lack of mammographic image review/interpretation functionality does not change RadUnity's intended use in relation to the primary predicate device or raise different questions of safety or effectiveness as compared to the Aquarius predicate device. | | | | | Equivalent to Equivalent to<br>Primary Predicate GE<br>Centricity PACS-IW<br>(K123174)- | | | | | The Centricity PACS-IW with | | | | | universal viewer secondary | | | | | predicate device is intended to | | | | | communicate, process and | | | | | display DICOM CT images | | | | | (and other DICOM modalities) | | | | | and transfer the images via the | | | | | DICOM protocol via the | | | | | network. Therefore, RadUnity | | | | | and the secondary predicate | | | | | Centricity PACS-IW with | | | | | universal viewer share the | | | | | same intended use. The | | |…