OnePacs System
Device Facts
| Record ID | K181460 |
|---|---|
| Device Name | OnePacs System |
| Applicant | Onepacs, LLC |
| Product Code | LLZ · Radiology |
| Decision Date | Oct 11, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.2050 |
| Device Class | Class 2 |
| Attributes | Software as a Medical Device |
Indications for Use
The OnePacs System is an image management system intended to provide scaleable DICOM compatible PACS solutions for hospitals and related institutions and sites, which will archive, distribute, retrieve and display images and data from all hospital modalities (such as CR, CT, DR, MR, and other devices) and information systems. This also includes the display of structured reports and mammography images that have been created according to DICOM "For Presentation", and will include standard features and other tools for analyzing mammography images. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretation. For primary diagnosis, post process DICOM "for presentation" images must be used. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images.
Device Story
OnePacs System is a software-only PACS for archiving, distributing, retrieving, and displaying multi-modality medical images (CR, CT, DR, MR) and structured reports. System components include OnePacs Cloud, Workstation (Windows/macOS), Webviewer, Study Retriever, and Gateway. Operates on generic PC hardware; enables secure transmission of studies from cloud to local workstations for radiologist interpretation. Provides standard visualization tools (W/L, zoom, pan, MPR, measurement, annotation). Supports DICOM standards for image exchange. Used by clinicians/radiologists in hospital/clinical settings to facilitate diagnostic workflows. Benefits include scalable, enterprise-wide access to medical imaging data and efficient reporting.
Clinical Evidence
No clinical data. Performance supported by comprehensive software validation and compliance with NEMA PS 3.1-3.20 (2016) and IEC/ISO 10918-1 standards.
Technological Characteristics
Software-only PACS; runs on generic PC hardware. Components: Cloud (multi-tenant), Workstation (Windows/macOS), Webviewer, Gateway. Connectivity: DICOM network, HL7 mapping. Standards: NEMA PS 3.1-3.20 (2016), IEC/ISO 10918-1 (JPEG compression). Languages: Java/JavaScript. Deployment: Cloud-based with local workstation clients.
Indications for Use
Indicated for hospitals and related institutions to archive, distribute, retrieve, and display medical images and data from all hospital modalities (CR, CT, DR, MR, etc.). Includes display of structured reports and mammography images. Contraindications: Lossy compressed mammographic images and digitized film screen images must not be used for primary diagnosis or interpretation.
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
Submission Summary (Full Text)
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October 11, 2018
OnePacs, LLC Justin Falk Director of IT 530 Lytton Ave PALO ALTO, CA 94301
Re: K181460
Trade/Device Name: OnePacs System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications System Regulatory Class: Class II Product Code: LLZ Dated: May 29, 2018 Received: September 11, 2018
Dear Justin Falk:
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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Hse 2. Nils
for Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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## Indications for Use
510(k) Number (if known)
K181460
Device Name OnePacs System
### Indications for Use (Describe)
The OnePacs System is an image management system intended to provide scaleable DICOM compatible PACS solutions for hospitals and related institutions and sites, which will archive, distribute, retrieve and display images and data from all hospital modalities (such as CR, CT, DR, MR, and other devices) and information systems. This also includes the display of structured reports and mammography images that have been created according to DICOM "For Presentation", and will include standard features and other tools for analyzing mammography images.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretation. For primary diagnosis, post process DICOM "for presentation" images must be used. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images.
| 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)
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# SECTION 5
# 510(k) Summary
K181460
#### 1. Sponsor
OnePacs, LLC 530 Lytton Ave Palo Alto, CA 94301 Phone: 877-881-7227 x117 Fax: 201-399-6580 Contact: Justin Falk Email: jfalk@onepacs.com
Summary Preparation Date: May 29, 2018
#### 2. Device
| Trade Name | OnePacs System |
|-------------------|----------------------------------------------------|
| Common Name | Picture archiving and communications system (PACS) |
| Classification | Class II |
| Product Code | LLZ |
| Regulation Number | 21 CFR 892.2050 |
| Review Panel | Radiology |
#### 3. Predicate Device
- · ClearCanvas RIS/ PACS (K110332)
- OsiriX MD (K101342)
#### 4. Device Description
The OnePacs System is an image management system intended to provide scaleable DICOM compatible PACS solutions for hospitals and related institutions and sites, which will archive, distribute, retrieve and display images and data from all hospital modalities (such as CR, CT, DR, MR, and other devices) and information systems.
The OnePacs system is a software only product and does not include any hardware accessories or peripheral devices. It is designed to work on generic PC hardware that meets minimum system requirements.
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The OnePacs System is comprised of following main interrelated software elements/ components:
- · OnePacs Cloud (OPS)
- · OnePacs Workstation (OPW)
- · OnePacs Workstation for macOS (OPX)
- · OnePacs Webviewer (OPWEBV)
- · OnePacs Study Retriever (OPSR)
- · OnePacs Gateway (OPG)
#### 5. Indications for Use
The OnePacs System is an image management system intended to provide scaleable DICOM compatible PACS solutions for hospitals and related institutions and sites, which will archive, distribute, retrieve and display images and data from all hospital modalities (such as CR, CT, DR, MR, and other devices) and information systems. This also includes the display of structured reports and mammography images that have been created according to DICOM "For Presentation", and will include standard features and other tools for analyzing mammography images.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretation. For primary diagnosis, post process DICOM "for presentation" images must be used. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images
#### 6. Technological Characteristics and Substantial Equivalence
The proposed OnePacs System is substantially equivalent to the referenced predicate devices in regard to the intended use, fundamental scientific technology, and technological characteristics, as outlined in the following table:
| Characteristic | Subject Device | Predicate Device | Predicate Device |
|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | OnePacs System | ClearCanvas RIS/PACS (K110332) | OsiriX MD (K101342) |
| Submitter | OnePacs LLC | ClearCanvas Inc. | Pixmeo, Sarl |
| Classification | Device Class: 2 Product Code: LLZ 21 CFR 892.2050 | Device Class: 2 Product Code: LLZ 21 CFR 892.2050 | Device Class: 2 Product Code: LLZ 21 CFR 892.2050 |
| Indications for Use | The OnePacs System is an image management system intended to provide scaleable DICOM compatible PACS solutions for hospitals and related institutions and | The ClearCanvas RIS/PACS is an image management system whose intended use is to provide scaleable DICOM compatible PACS solutions for hospitals and | OsiriX MD is a software device intended for viewing of images acquired from CT, MR, CR, DR, US and other DICOM compliant medical |
| Characteristic | Subject Device | Predicate Device | Predicate Device |
| Trade Name | OnePacs System | ClearCanvas RIS/PACS<br>(K110332) | OsiriX MD (K101342) |
| | sites, which will archive,<br>distribute, retrieve and<br>display images and data<br>from all hospital modalities<br>(such as CR, CT, DR, MR,<br>and other devices) and<br>information systems. This<br>also includes the display of<br>structured reports and<br>mammography images<br>that have been created<br>according to DICOM "For<br>Presentation", and will<br>include standard features<br>and other tools for<br>analyzing mammography<br>images.<br>Lossy compressed<br>mammographic images<br>and digitized film screen<br>images must not be<br>reviewed for primary<br>diagnosis or image<br>interpretation. For primary<br>diagnosis, post process<br>DICOM "for presentation"<br>images must be used.<br>Mammographic images<br>should only be viewed with<br>a monitor approved by<br>FDA for viewing<br>mammographic images. | related institutions and<br>sites, which will archive,<br>distribute, retrieve and<br>display images and data<br>from all hospital<br>modalities (such as CR,<br>CT, DR, MR, and other<br>devices) and information<br>systems. This also<br>includes the display of<br>structured reports and<br>mammography images<br>that have been created<br>according to DICOM "For<br>Presentation", and will<br>include standard features<br>and other tools for<br>analyzing mammography<br>images.<br>Lossy compressed<br>mammography images<br>and digitized film screen<br>images must not be used<br>for primary image<br>interpretations.<br>Mammography images<br>may only be interpreted<br>using an FDA approved<br>monitor that offers at least<br>5 mega-pixel resolution<br>and meets other technical<br>specifications approved<br>by the FDA. | imaging systems when<br>installed on suitable<br>commercial standard<br>hardware.<br>Images and data can be<br>captured, stored,<br>communicated,<br>processed, and displayed<br>within the system and or<br>across computer<br>networks at distributed<br>locations.<br>Lossy compressed<br>mammographic images<br>and digitized film screen<br>images must not be<br>reviewed for primary<br>diagnosis or image<br>interpretation. For primary<br>diagnosis, post process<br>DICOM "for presentation"<br>images must be used.<br>Mammographic images<br>should only be viewed<br>with a monitor approved<br>by FDA for viewing<br>mammographic images.<br>It is the User's<br>responsibility to ensure<br>monitor quality, ambient<br>light conditions, and<br>image compression ratios<br>are consistent with the<br>clinical application. |
| Characteristic | Subject Device | Predicate Device | Predicate Device |
| Trade Name | OnePacs System | ClearCanvas RIS/PACS<br>(K110332) | OsiriX MD (K101342) |
| Prescription /<br>Over-The-<br>Counter (OTC)<br>Use | Prescription Use | Prescription Use | Prescription Use |
| Device<br>Description and<br>Key<br>Components | The OnePacs System<br>software is primarily<br>written in Java/ Javascript.<br>The system is designed to<br>work on generic PC<br>hardware that meets<br>minimum system<br>requirements.<br>The OnePacs System is<br>comprised of following<br>interrelated software<br>components:<br>OnePacs Cloud<br>OnePacs Application<br>Server is inherently<br>enterprise wide, deployed<br>in multi-tenant cloud<br>architecture. The OnePacs<br>Cloud allows medical<br>studies to be securely<br>transmitted so that a<br>physician may view and<br>interpret the study and<br>complete the medical<br>report.<br>OnePacs Workstation<br>(OPW) & OnePacs<br>Workstation for macOS<br>(OPX)<br>Communicates with<br>OnePacs Server for image<br>retrieval and metadata.<br>The OPW and OPX<br>provide navigation and<br>visualization of multi-<br>modality and<br>multidimensional images.<br>They act as DICOM viewer<br>capable of connecting to a<br>DICOM network<br>OnePacs Web Viewer<br>(OPWEBV)<br>enables the display and | ClearCanvas RIS/PACS<br>software is primarily<br>written in C#, employing<br>the most current best<br>practices in object<br>oriented and component-<br>oriented software<br>architecture resulting in a<br>highly scalable and<br>extensible design. The<br>system is also designed<br>to work on generic PC<br>hardware that meets the<br>minimum system<br>requirements.<br>The ClearCanvas<br>RIS/PACS is a system of<br>interrelated software<br>components:<br>ClearCanvas Workstation<br>a desktop client that is<br>primarily used to retrieve,<br>display, enhance and<br>analyze medical images.<br>Access to patient<br>demographic data is also<br>possible through the<br>Workstation when<br>working with the RIS<br>server.<br>ClearCanvas Webstation<br>a browser-based web<br>application that allows the<br>user to retrieve images<br>from the ImageServer for<br>review. Primarily intended<br>for referring physicians<br>and as an image viewer<br>for EMR systems, the<br>images are JPEG-<br>compressed.<br>ClearCanvas<br>ImageServer | The OsiriX MD software is<br>an interactive image<br>display and navigation<br>program that was<br>designed to display<br>medical imaging<br>modalities. It supports all<br>types of images<br>generated by variety of<br>imaging equipment and<br>scanners available today.<br>lt supports the DICOM<br>standard for image<br>communication as well as<br>a variety of other image<br>formats used in academic<br>and research community.<br>OsiriX MD is tailored for<br>large sets of<br>multidimensional and<br>multi-modality images<br>such as combined PET-<br>CT studies that require<br>three-dimensional image<br>fusion and volume<br>rendering. The software is<br>developed on a<br>Macintosh platform taking<br>advantage of the<br>underlying UNIX kernel of<br>the Mac OS X operating<br>optimized 3D graphic<br>capabilities of Open GL<br>graphic standard that is<br>widely used for computer<br>games and animations<br>and is highly optimized on<br>the Macintosh platform for<br>taking advantage of any<br>hardware graphic<br>accelerator boards that<br>would be available. The<br>software was developed<br>in Objective-C in Apple<br>Cocoa development<br>environment. In the<br>design of the software a |
| Characteristic | Subject Device | Predicate Device | Predicate Device |
| Trade Name | OnePacs System | ClearCanvas RIS/PACS<br>(K110332) | OsiriX MD (K101342) |
| | review of medical images<br>OnePacs Study Retriever<br>(OPSR)<br>facilitates the secure<br>transmission of medical<br>images from the OnePacs<br>Cloud servers to the local<br>desktop of a radiologist.<br>OnePacs Gateway (OPG)<br>a gateway or bridge to the<br>OnePacs Cloud. The OPG<br>software enables access<br>to the cloud by offering the<br>following functionality. It<br>provides DICOM image<br>routing, security, and<br>compression, HL7<br>mapping connectivity and<br>mapping | a server application that<br>receives images from<br>imaging modalities, stores<br>and archives them, and<br>distributes them to client<br>applications.<br>ClearCanvas RIS<br>a server application that<br>acts as an online<br>transaction processor for<br>the management<br>of patient and workflow<br>information.<br>ClearCanvas<br>IntegrationServer<br>a server application<br>composed of optional<br>modules that implement<br>integration and<br>interoperability, such as<br>an inbound and outbound<br>HL7 processor.<br>ClearCanvas<br>EnterpriseServer a server<br>application that provides<br>enterprise-wide facilities<br>such as user<br>authentication,<br>authorization and<br>auditing. | special attention was<br>given to adapt the user<br>interface to navigating<br>through large sets of<br>image data. The graphical<br>user interface also uses<br>the Macintosh interface.<br>Users can change and<br>customize the software by<br>adding and removing<br>tools and items from the<br>program toolbar and<br>menu bars. This allows<br>for adapting the software<br>for number of functions<br>and avoiding the users to<br>be overwhelmed by an<br>excessive number of<br>unnecessary tools and<br>functions that are not<br>always needed. |
| Operating<br>system/<br>platform | Windows, Mac OS X<br>(Apple), Linux | Windows | Mac OS X (Apple) |
| Device type/<br>form | Software device that<br>operates on off-the-shelf<br>hardware | Software device that<br>operates on off-the-shelf<br>hardware | Software device that<br>operates on off-the-shelf<br>hardware |
| Mode of<br>delivery/<br>installation | OnePacs System is to be<br>downloaded from<br>OnePacs Cloud.<br>The OPX component is<br>provided as a macOS<br>package download. The<br>package is installed<br>through the macOS<br>Installer tool. | Installation from optical<br>media and/or download<br>from the server | OsiriX MD is provided as<br>a DMG (Apple Disk<br>Image) download. When<br>mounted, the DMG offers<br>an installer application to<br>be executed by the user. |
| Characteristic<br>Trade Name | Subject Device<br>OnePacs System | Predicate Device<br>ClearCanvas RIS/PACS<br>(K110332) | Predicate Device<br>OsiriX MD (K101342) |
| Functions and<br>Capabilities | | | |
| Query, Import,<br>Send, Receive<br>DICOM images | Yes…
