(69 days)
No
The summary describes image management, processing, and workflow standardization based on predefined user preferences, without mentioning any AI or ML techniques for image analysis or decision-making.
No
The device processes and reformats medical images for viewing, but it does not directly treat or prevent a disease, nor does it restore, modify, or correct body function. Its purpose is workflow management and standardization of CT images for interpretation by professionals, not therapeutic intervention.
No
The document explicitly states, "RadUnity is not intended for primary diagnostic review." It functions as an image management and workflow management system that processes and reformats images for later interpretation, rather than performing the diagnostic interpretation itself.
Yes
The device description explicitly states "RadUnity is stand-alone software device (SaMD)". The description focuses entirely on software functions like image management, digital image processing, and workflow management, with no mention of accompanying hardware components being part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens derived from the human body. The description of RadUnity clearly states it receives and processes medical images from CT imaging acquisition devices. It does not interact with or analyze biological samples like blood, urine, or tissue.
- The intended use is for image management and processing for viewing by qualified radiology professionals. While the processed images might be used in the diagnostic process, RadUnity itself is not performing a diagnostic test on a biological specimen. Its function is to standardize and manage image data.
- The device description focuses on workflow management and image reformatting. This aligns with a picture archiving and communication system (PACS) or image processing software, not an IVD.
- The predicate devices listed (Terarecon AquariusAPS Server and GE Centricity PACS-IW with Universal Viewer) are also image management and processing systems, not IVDs.
In summary, RadUnity is a software device that handles and processes medical images, which falls under the category of medical imaging software or PACS, not in vitro diagnostics.
N/A
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.
Product codes
LLZ
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.
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT imaging acquisition devices
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified radiology professionals and specialists.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
9.1.2.Software Verification and Validation Testing
Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
The software verification and validation testing verified that the design requirements were successfully met. The Intended use and user needs were successfully validated.
RadUnity includes Cybersecurity functionality and information which conforms to FDA's September 23, 2023 °Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions' guidance.
RadUnity conforms with DICOM standards (i.e., NEMA DICOM PS3.5 2024e).
RadUnity's validation activities included Usability validation testing which was performed by U.S. Board Certified Radiologists.
As the intended use, functionality and performance of the subject device and the predicate device are equivalent, the result of the performance testing is evidence that the RadUnity performs in an equivalent manner to the AquariusAPS Server primary predicate and secondary predicate devices.
9.2.Clinical Performance Testing
No clinical performance data was necessary to claim substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.2050 Medical image management and processing system.
(a)
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.(b)
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).
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.
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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 |
| 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 |
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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 | |
| Number | K061214 |
| Product Code | LLZ |
| Regulation Number | 21 CFR 892.2050 |
| Regulation Name | Picture Archiving and Communications |
| System | |
| Class | 2 |
| Review Panel | Radiology |
4. SECONDARY PREDICATE DEVICE INFORMATION
| Predicate Device Name | Centricity PACS-IW with Universal Viewer |
|---|---|
| Predicate Device K | |
| Number | K123174 |
| Product Code | LLZ |
| Regulation Number | 21 CFR 892.2050 |
| Regulation Name | Picture Archiving and Communications |
| 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
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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 |
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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) |
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)
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)
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)-
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.
Additionally, RadUnity does not process raw sinogram or projection data from CT images which is equivalent to the AquariusAPS server
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
Primary Predicate GE
Centricity PACS-IW
(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 | |
| | | Centricity PACS-IW with | |
| | | universal viewer device | |
| | | supports additional DICOM | |
| | | imaging modalities and image | |
| | | review functionality that are | |
| | | not needed by RadUnity to | |
| | | accomplish it's intended use in | |
| | | a safe and effective manner. | |
| | | The Centricity PACS-IW with | |
| | | universal viewer secondary | |
| | | predicate device includes the | |
| | | technological characteristic of | |
| | | 'Smart Reading Protocols | |
| | | (SPR)'. This characteristic | |
| | | allows the user to set the image | |
| | | 'view' for source volumes and | |
| | | then apply the view to future | |
| | | images. This technologic | |
| | | characteristic is equivalent to | |
| | | RadUnity's 'Profiles' which | |
| | | allows the user to configure | |
| | | source volume specific profile | |
| | | mapping and apply it to future | |
| | | images. This characteristic is | |
| | | the reason for selecting the | |
| | | Centricity PACS-IW with | |
| | | universal viewer as a | |
| | | secondary predicate device. | |
510(k) SummaryPage 5 of 19
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(Per 21 CFR 807.92)
510(k) Summary Page 6 of 19
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| 510(k) Summary |
|---|
| Page 7 of 19 |
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| | | RadUnity and the Centricity
PACS-IW with universal
viewer device have an
equivalent intended use. The
differences do not raise
different questions of safety or
effectiveness. |
|--|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Summary |
|---|
| Page 8 of 19 |
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(Per 21 CFR 807.92)
8.4.Predicate Device Comparison Table
| Characteristic | RadUnity (Version 1.0.0) | AquariusAPS server (K061214) (Primary Predicate) | Centricity PACS-IW with Universal Viewer (K123174) (Secondary Predicate) | SE Discussion |
|---|---|---|---|---|
| Regulation Number | 21 CFR 892.2050 | 21 CFR 892.2050 | 21 CFR 892.2050 | Same |
| Regulation Name | Medical image management and processing system | Picture archiving and communications system | Picture archiving and communications system | FDA regulation name has changed for 21 CFR 892.2050 from 'Picture archiving and communications system' to 'Medical image management and processing system'. The update in name does not fundamentally change the purpose/intended use of the associated medical devices. |
| Product Code | LLZ | LLZ | LLZ | Same |
| Regulatory Class | 2 | 2 | Same | |
| Submission type | 510(k) | 510(k) | Same | |
| GMP Exempt | No | No | No | Same |
| Characteristic | RadUnity (Version
1.0.0) | AquariusAPS server
(K061214)
(Primary Predicate) | Centricity PACS-IW
with Universal Viewer
(K123174)
(Secondary Predicate) | SE Discussion |
|------------------------------------------|-----------------------------|--------------------------------------------------------|-----------------------------------------------------------------------------------|---------------|
| Technological Characteristics Comparison | | | | |
| 510(k) Summary |
|---|
| Page 9 of 19 |
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| Characteristic | RadUnity (Version
1.0.0) | AquariusAPS server
(K061214)
(Primary Predicate) | Centricity PACS-IW
with Universal Viewer
(K123174)
(Secondary Predicate) | SE Discussion |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Type | Software medical
Device (SaMD) | Software medical
Device (SaMD) | Software medical
Device (SaMD) | Same- Both the subject and
predicate devices are SaMD |
| Operating
Environment | Local web browser-
based user-facing
application, network
server for image
processing utilizing
commercially
available
computer platforms
and operating
systems. | Locally installed user-
facing application,
network server for
image processing
utilizing commercially
available computer
platforms and
operating systems. | Deployed over
conventional TCP/IP
networking
infrastructure
available in most
healthcare
organizations and
utilizes commercially
available
computer platforms
and operating
systems. | Equivalent-
RadUnity utilizes a locally
installed Web browser
based user-facing graphical
user interface (GUI) which
communicates to a local
image processing server.
This configuration is
equivalent to the primary
and secondary predicate
device operating
environment
configurations.
There may be minor
differences between
RadUnity and the predicate
devices for this
technological characteristic.
However, these do not raise
any different questions on
safety of effectiveness of
the RadUnity device as
compared to the predicate
devices. |
| 510(k) Summary |
|---|
| Page 10 of 19 |
14
Image /page/14/Picture/0 description: The image shows the word "RadUnity" in bold, black font. Below the word is a graphic that appears to be a stylized representation of radiation. The graphic includes three wavy lines that converge into a black circle, from which three straight lines extend.
| Characteristic | RadUnity (Version
1.0.0) | AquariusAPS server
(K061214)
(Primary Predicate) | Centricity PACS-IW
with Universal Viewer
(K123174)
(Secondary Predicate) | SE Discussion |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Computer
Hardware | RadUnity software
runs on industry
standard computer
hardware which
meets the minimum
specification. | AquariusAPS server
software runs on
industry standard
computer hardware
which meets the
minimum specification. | Centricity PACS-IW
with universal viewer
server software runs
on industry standard
computer hardware
which meets the
minimum specification | Equivalent-
The subject RadUnity device
and the predicate devices
utilize commercially
available computer
platforms and operating
systems. The specifics may
differ to some degree based
on the timeframes in which
the predicate devices were
cleared. However, this does
not raise any different
questions on safety of
effectiveness of the device. |
| Operating
Systems
Supported | Computer running
Microsoft Windows
10/11 with Microsoft
Edge (minimum
supported version
128) and Google
Chrome browsers
(minimum version
126) | Microsoft Windows,
Internet Explorer | Microsoft Windows,
Internet Explorer | Equivalent-
The RadUnity subject
device, the primary and
secondary predicate device
utilize the Microsoft
Windows OS as well as an
Internet Browser. The
subject RadUnity versions
are more current than the
predicate's due to the
timeframe that the devices
were cleared. However, this
does not raise any different
questions on safety of
effectiveness of the
RadUnity device. |
| 510(k) Summary |
|---|
| Page 11 of 19 |
15
Image /page/15/Picture/0 description: The image shows the word "RadUnity" in bold, black font. Below the word is a graphic that includes three sine waves on the left, a black rounded square in the middle, and three horizontal lines on the right. The sine waves appear to be connected to the left side of the rounded square, and the horizontal lines are connected to the right side of the rounded square.
| Characteristic | RadUnity (Version
1.0.0) | AquariusAPS server
(K061214)
(Primary Predicate) | Centricity PACS-IW
with Universal Viewer
(K123174)
(Secondary Predicate) | SE Discussion |
|---------------------------|-----------------------------|----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Graphic User
Interface | Web browser based | Web browser based | Web browser based | Equivalent-
The subject RadUnity device
as well as the primary and
secondary predicate devices
utilize a Web-based
browser.
There may be minor
differences for this
technological characteristic
between RadUnity and the
predicate devices. However
these do not raise any
different questions on
safety of effectiveness. |
| Image input
type | DICOM CT images | DICOM CT, EBT, MRI
and other volumetric or NM,CR,PET, DX, XA
planar images | DICOM CT, MRI, US,
and other DICOM
images | Equivalent-
The subject RadUnity device
is currently intended to use
only DICOM CT images. The
primary and secondary
predicates include
additional DICOM imaging
modalities. RadUnity and
the predicate devices are
equivalent in terms of
DICOM CT image input type.
RadUnity's intended use
does not require other
DICOM image types.
This difference does not
raise any new questions of
safety and effectiveness. |
| 510(k) Summary |
|---|
| Page 12 of 19 |
16
Image /page/16/Picture/0 description: The image shows the word "RadUnity" in bold, black font. Below the word is a graphic that includes three wavy lines that connect to a black square. Three straight lines extend from the other side of the black square. The image is simple and uses a limited color palette.
| Characteristic | RadUnity (Version
1.0.0) | AquariusAPS server
(K061214)
(Primary Predicate) | Centricity PACS-IW
with Universal Viewer
(K123174)
(Secondary Predicate) | SE Discussion |
|------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Interoperability | RadUnity receives (as input), CT images
from CT acquisition
devices which use
DICOM transfer
protocols.
RadUnity transfers
the processed images
using DICOM transfer
protocols | AquariusAPS server
receives (as input), CT,
EBT, MRI and other
volumetric or planar
medical imaging
modalities, from
imaging acquisition
devices which uses
DICOM transfer
protocols.
AquariusAPS server
transfers the processed
images using DICOM
transfer protocols | Centricity PACS-IW
with Universal Viewer
receives (as input), CT,
US, NM, MRI and
other medical imaging
modalities, from
imaging acquisition
devices which uses
DICOM transfer
protocols.
Centricity PACS-IW
with Universal Viewer
is designed to be
deployed over
conventional TCP/IP
networking
infrastructure
available in most
healthcare
organizations | Equivalent-
RadUnity and the primary
and secondary predicate
devices are intended to
receive DICOM CT images
from image acquisition
devices and transfer the
processed images using the
DICOM transfer protocol.
There may be minor
differences for this
technological characteristic
between RadUnity and the
predicate devices. However,
these do not raise any
different questions on
safety of effectiveness. |
| DICOM Tags | RadUnity is capable
of performing actions
based on DICOM tags
contained in images | AquariusAPS server is
capable of performing
actions based on
DICOM tags contained
in images | Centricity PACS-IW
with Universal Viewer
is capable of
performing actions
based on DICOM tags
contained in images | Equivalent-
RadUnity and the primary
and secondary predicate
devices perform actions
based on DICOM tags.
There may be minor
differences for this
technological characteristic
between RadUnity and the
predicate devices. However,
these do not raise any
different questions on
safety of effectiveness. |
| 510(k) Summary |
|---|
| Page 13 of 19 |
17
Image /page/17/Picture/0 description: The image shows the word "RadUnity" in bold, black font. Below the word is a graphic that includes three wavy lines on the left, connected to a black square in the middle. Three straight lines extend from the right side of the black square.
| Characteristic | RadUnity (Version
1.0.0) | AquariusAPS server
(K061214)
(Primary Predicate) | Centricity PACS-IW
with Universal Viewer
(K123174)
(Secondary Predicate) | SE Discussion |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Image
Presentation | RadUnity's Profile
Builder user interface
allows the user to
control image
generation and
presentation
settings. | AquariusAPS includes
an 'Auto Batch'
function which is used
to automatically
generate reformatted
images. | Centricity PACS-IW
with Universal Viewer,
user interface allows
the user to control
image presentation
and generation
settings. | Equivalent-
RadUnity and the primary
(AquariusAPS) and
secondary predicate
(Centricity PACS-IW with
Universal Viewer) have
equivalent functionality in
terms of image
presentation/generation
settings. There may be
minor differences for this
technological characteristic
between RadUnity and the
predicate devices. However
these do not raise any
different questions on
safety of effectiveness. |
| 510(k) Summary |
|---|
| Page 14 of 19 |
18
Image /page/18/Picture/0 description: The image shows the word "RadUnity" in bold, black font. Below the word is a graphic of three wavy lines that connect to a black circle. Three straight lines extend from the other side of the circle. The image is in black and white.
| Characteristic | RadUnity (Version
1.0.0) | AquariusAPS server
(K061214)
(Primary Predicate) | Centricity PACS-IW
with Universal Viewer
(K123174)
(Secondary Predicate) | SE Discussion |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Image
Management | RadUnity 'maps'
profiles to specific
exam types (e.g., by
telling RadUnity the
typical order/study
description and
scanner protocols
used for the exam
type)
RadUnity allows the
user to configure
source volume
specific profile
mapping and apply it
to future images. The
user can also modify
reconstruction
extents (i.e., what
part of a source
volume is used for
RadUnity processing
for a specific profile
reformat). | AquariusAPS server is
capable of creating
images and image
sequences in a variety
of formats. However, it
is not known whether
the AquariusAPS Server
device is capable of
applying those formats
to future images. | The Smart Reading
Protocols (SPR) within
the Centricity PACS-IW
with Universal Viewer
allows the user to set
the image 'view' for
source volumes and
then apply the view to
future images. | Equivalent-
RadUnity 's ability to
configure source volume
specific profile mapping is
most equivalent to the
secondary predicate's
(Centricity PACS-IW) Smart
Reading Protocols (SPR) as
the setting for source
volumes and the application
of the setting(s) to future
images is equivalent. The
primary predicate
(AquariusAPS server) can
create image/sequences in
a variety of formats.
However, it is not known
whether the Aquarius
device is capable of
applying those formats to
future images.
RadUnity's functionality is
equivalent to the secondary
predicate's as the outcome
is essentially the same and
therefore would be
equivalent in terms of
safety and effectiveness. |
| 510(k) Summary |
|---|
| Page 15 of 19 |
19
Image /page/19/Picture/0 description: The image shows the word "RadUnity" in bold, black font. Below the word is a symbol that appears to be a black square with rounded corners. To the left of the square are two wavy lines, and to the right are three straight, horizontal lines.
| Characteristic | RadUnity (Version
1.0.0) | AquariusAPS server
(K061214)
(Primary Predicate) | Centricity PACS-IW
with Universal Viewer
(K123174)
(Secondary Predicate) | SE Discussion |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Image
processing
functionality | RadUnity has the
following image
processing
functionality:
• Filtering
◦ Smoothing
◦ Edge
Enhancement
• Multiplanar
Reformatting
(MPR)
• Maximum
Intensity
Projection (MIP)
• Minimum
Intensity
Projection
(MinIP) | AquariusAPS server has
the following image
processing
functionality:
• Filtering
• Multiplanar
Reformatting
(MPR)
• Maximum
Intensity
Projection (MIP)
• Minimum
Intensity
Projection (MinIP) | Centricity PACS-IW
with Universal Viewer
has the following
image processing
functionality:
• Edge
enhancement
• Changing the
image plane
from one plane
to another
• Multiplanar
Reformatting
(MPR)
• Maximum
Intensity
Projection
(MIP)
• Minimum
Intensity
Projection
(MinIP) | Equivalent-
The subject RadUnity device
and the predicate devices
have equivalent imaging
processing functionality.
Minor differences do not
raise any new questions of
safety and effectiveness. |
| 510(k) Summary |
|---|
| Page 16 of 19 |
20
Image /page/20/Picture/0 description: The image shows the word "RadUnity" in bold, black font. Below the word is a graphic that appears to be a stylized representation of radiation. The graphic includes three wavy lines that converge into a black circle, from which three straight lines extend.
| Characteristic | RadUnity (Version
1.0.0) | AquariusAPS server
(K061214)
(Primary Predicate) | Centricity PACS-IW
with Universal Viewer
(K123174)
(Secondary Predicate) | SE Discussion |
|----------------|----------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Image Export | RadUnity is capable
of exporting
reformatted images
and image sequences
to DICOM capable
destinations | AquariusAPS server is
capable of exporting
reformatted images
and image sequences
to DICOM capable
destinations | Centricity PACS-IW
with Universal Viewer
is capable of exporting
reformatted images
and image sequences
to DICOM capable
destinations | Equivalent-
The subject RadUnity device
and the primary
AquariusAPS server are
intended to perform image
processing/reformatting
and transfer the images via
the DICOM protocol to an
image review system. |
| | | | | The secondary Centricity
PACS-IW with Universal
Viewer device is also
capable of exporting images
and image sequences to
DICOM capable destinations
but includes an image
review system. |
| | | | | RadUnity and the primary
(AquariusAPS) and
secondary predicate
(Centricity PACS-IW with
Universal Viewer) have
equivalent functionality in
terms of image
image/sequence |
| | | | | exportation. There may be
minor differences for this
technological characteristic
between RadUnity and the
predicate devices. However,
these do not raise any
different questions on
safety of effectiveness. |
| 510(k) Summary |
|---|
| Page 17 of 19 |
21
Image /page/21/Picture/0 description: The image shows the word "RadUnity" in bold, black font. Below the word is a graphic that includes three horizontal lines, two wavy lines, and a black square with rounded corners. The graphic appears to be a stylized representation of radiation or energy. The overall design is simple and clean, with a focus on the text and the graphic element.
(Per 21 CFR 807.92)
| Characteristic | RadUnity (Version
1.0.0) | AquariusAPS server
(K061214)
(Primary Predicate) | Centricity PACS-IW
with Universal Viewer
(K123174)
(Secondary Predicate) | SE Discussion |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Automation
functionality | RadUnity includes
'Profile' functionality
which allows the user
to set up the images
in a user-preferred
layout: layout, image
series placement,
automatic post-
processing, etc.. | AquariusAPS server
includes 'Autobatch'
functionality.
AutoBatch generates
reformatted images on
CT data that has been
pushed to the
AquariusAPS server. | Centricity PACS-IW
with Universal Viewer
includes 'Smart
Reading Protocols'
(SRP). SRP's allow the
user to set up the
images in a user-
preferred layout:
viewports layout,
image series
placement, automatic
post-processing, etc.. | Equivalent-
The subject RadUnity
device's Profile'
functionality is equivalent
to the primary predicate
AquariusAPS server's
'Autobatch' functionality
and the secondary
predicate Centricity PACS-
IW with Universal Viewer's
'Smart Reading Protocols'
functionality. The secondary
predicate's 'Smart Reading
Protocols' appear to be a
closer match to RadUnity's
'Profiles' functionality than
the primary predicate's
'Autobatch' functionality.
The differences between
RadUnity's and the 'Profiles'
functionality and Centricity
PACS-IW with Universal
Viewer 'Smart Reading
Protocols' do not raise new
questions relating to safety
or effectiveness. |
9. PERFORMANCE DATA
9.1.Software Verification and Validation Testing
Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
| 510(k) Summary |
|---|
| Page 18 of 19 |
22
Image /page/22/Picture/0 description: The image shows the word "RadUnity" in bold, black font. Below the word is a black square with rounded corners. To the left of the square are three wavy lines, and to the right of the square are three straight lines. The lines appear to be connected to the square.
(Per 21 CFR 807.92)
The software verification and validation testing verified that the design requirements were successfully met. The Intended use and user needs were successfully validated.
RadUnity includes Cybersecurity functionality and information which conforms to FDA's September 23, 2023 °Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions' guidance.
RadUnity conforms with DICOM standards (i.e., NEMA DICOM PS3.5 2024e).
RadUnity's validation activities included Usability validation testing which was performed by U.S. Board Certified Radiologists.
As the intended use, functionality and performance of the subject device and the predicate device are equivalent, the result of the performance testing is evidence that the RadUnity performs in an equivalent manner to the AquariusAPS Server primary predicate and secondary predicate devices.
9.2.Clinical Performance Testing
No clinical performance data was necessary to claim substantial equivalence.
10. CONCLUSION
The RadUnity device shares similar technological characteristics, intended use, and functionality with the predicate devices. There are no differences between the devices that raise new questions of safety and effectiveness.
Furthermore, non-clinical performance test data and software verification and validation demonstrate that RadUnity performs comparably to the predicate device in terms of safety and effectiveness.
Based on the device comparisons and the acceptable testing results, it is determined that RadUnity is substantially equivalent to the predicate devices.
| 510(k) Summary |
|---|
| Page 19 of 19 |