Who is the manufacturer of OnePacs System?

Onepacs, LLC filed the 510(k) submission for OnePacs System (K181460).

What is the FDA product code for OnePacs System?

LLZ. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for OnePacs System?

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

Who can help prepare an FDA 510(k) submission like OnePacs System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

OnePacs System

Q: What are the predicate devices for OnePacs System?

ClearCanvas RIS/ PACS (K110332); OsiriX MD (K101342).

K181460 · Onepacs, LLC · LLZ · Oct 11, 2018 · Radiology

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

Intended 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

ClearCanvas RIS/ PACS (K110332)
OsiriX MD (K101342)

Related Devices

K141561 — VM PACS WITH VM MEDICAL WORKSTATION · Visual Medica · Jan 16, 2015
K070618 — DICOMPACS, MODEL 5 · Oehm Und Rehbein GmbH · Apr 25, 2007
K132586 — PAXERAPACS · Paxeramed · Oct 31, 2013
K140797 — IPACS MEDICAL IMAGE MANAGEMENT SYSTEM · Visbion Limited · Dec 12, 2014
K250039 — HPACS · Healthhub · Oct 3, 2025

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains two logos. On the left is the logo for the Department of Health & Human Services - USA, featuring a stylized human figure. To the right is the logo for the U.S. Food & Drug Administration (FDA), with the FDA acronym in a blue square and the full name "U.S. FOOD & DRUG ADMINISTRATION" written in blue text. 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ ## 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) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 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. {4}------------------------------------------------ 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 (K110332) | OsiriX MD (K101342) | | | 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. | 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 mammography images and digitized film screen images must not be used for primary image interpretations. Mammography images may only be interpreted using an FDA approved monitor that offers at least 5 mega-pixel resolution and meets other technical specifications approved by the FDA. | imaging systems when installed on suitable commercial standard hardware. Images and data can be captured, stored, communicated, processed, and displayed within the system and or across computer networks at distributed locations. 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. It is the User's responsibility to ensure monitor quality, ambient light conditions, and image compression ratios are consistent with the clinical application. | | Characteristic | Subject Device | Predicate Device | Predicate Device | | Trade Name | OnePacs System | ClearCanvas RIS/PACS (K110332) | OsiriX MD (K101342) | | Prescription / Over-The- Counter (OTC) Use | Prescription Use | Prescription Use | Prescription Use | | Device Description and Key Components | The OnePacs System software is primarily written in Java/ Javascript. The system is designed to work on generic PC hardware that meets minimum system requirements. The OnePacs System is comprised of following interrelated software components: OnePacs Cloud OnePacs Application Server is inherently enterprise wide, deployed in multi-tenant cloud architecture. The OnePacs Cloud allows medical studies to be securely transmitted so that a physician may view and interpret the study and complete the medical report. OnePacs Workstation (OPW) & OnePacs Workstation for macOS (OPX) Communicates with OnePacs Server for image retrieval and metadata. The OPW and OPX provide navigation and visualization of multi- modality and multidimensional images. They act as DICOM viewer capable of connecting to a DICOM network OnePacs Web Viewer (OPWEBV) enables the display and | ClearCanvas RIS/PACS software is primarily written in C#, employing the most current best practices in object oriented and component- oriented software architecture resulting in a highly scalable and extensible design. The system is also designed to work on generic PC hardware that meets the minimum system requirements. The ClearCanvas RIS/PACS is a system of interrelated software components: ClearCanvas Workstation a desktop client that is primarily used to retrieve, display, enhance and analyze medical images. Access to patient demographic data is also possible through the Workstation when working with the RIS server. ClearCanvas Webstation a browser-based web application that allows the user to retrieve images from the ImageServer for review. Primarily intended for referring physicians and as an image viewer for EMR systems, the images are JPEG- compressed. ClearCanvas ImageServer | The OsiriX MD software is an interactive image display and navigation program that was designed to display medical imaging modalities. It supports all types of images generated by variety of imaging equipment and scanners available today. lt supports the DICOM standard for image communication as well as a variety of other image formats used in academic and research community. OsiriX MD is tailored for large sets of multidimensional and multi-modality images such as combined PET- CT studies that require three-dimensional image fusion and volume rendering. The software is developed on a Macintosh platform taking advantage of the underlying UNIX kernel of the Mac OS X operating optimized 3D graphic capabilities of Open GL graphic standard that is widely used for computer games and animations and is highly optimized on the Macintosh platform for taking advantage of any hardware graphic accelerator boards that would be available. The software was developed in Objective-C in Apple Cocoa development environment. In the design of the software a | | Characteristic | Subject Device | Predicate Device | Predicate Device | | Trade Name | OnePacs System | ClearCanvas RIS/PACS (K110332) | OsiriX MD (K101342) | | | review of medical images OnePacs Study Retriever (OPSR) facilitates the secure transmission of medical images from the OnePacs Cloud servers to the local desktop of a radiologist. OnePacs Gateway (OPG) a gateway or bridge to the OnePacs Cloud. The OPG software enables access to the cloud by offering the following functionality. It provides DICOM image routing, security, and compression, HL7 mapping connectivity and mapping | a server application that receives images from imaging modalities, stores and archives them, and distributes them to client applications. ClearCanvas RIS a server application that acts as an online transaction processor for the management of patient and workflow information. ClearCanvas IntegrationServer a server application composed of optional modules that implement integration and interoperability, such as an inbound and outbound HL7 processor. ClearCanvas EnterpriseServer a server application that provides enterprise-wide facilities such as user authentication, authorization and auditing. | special attention was given to adapt the user interface to navigating through large sets of image data. The graphical user interface also uses the Macintosh interface. Users can change and customize the software by adding and removing tools and items from the program toolbar and menu bars. This allows for adapting the software for number of functions and avoiding the users to be overwhelmed by an excessive number of unnecessary tools and functions that are not always needed. | | Operating system/ platform | Windows, Mac OS X (Apple), Linux | Windows | Mac OS X (Apple) | | Device type/ form | Software device that operates on off-the-shelf hardware | Software device that operates on off-the-shelf hardware | Software device that operates on off-the-shelf hardware | | Mode of delivery/ installation | OnePacs System is to be downloaded from OnePacs Cloud. The OPX component is provided as a macOS package download. The package is installed through the macOS Installer tool. | Installation from optical media and/or download from the server | OsiriX MD is provided as a DMG (Apple Disk Image) download. When mounted, the DMG offers an installer application to be executed by the user. | | Characteristic Trade Name | Subject Device OnePacs System | Predicate Device ClearCanvas RIS/PACS (K110332) | Predicate Device OsiriX MD (K101342) | | Functions and Capabilities | | | | | Query, Import, Send, Receive DICOM images | Yes…

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Device Facts

Intended Use

Device Story

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Indications for Use

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Submission Summary (Full Text)

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