Who is the manufacturer of ONIS-PACS?

Digitalcore Co., Ltd. filed the 510(k) submission for ONIS-PACS (K181318).

What is the FDA product code for ONIS-PACS?

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

What is the regulatory pathway for ONIS-PACS?

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

Who can help prepare an FDA 510(k) submission like ONIS-PACS?

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.

ONIS-PACS

K181318 · Digitalcore Co., Ltd. · LLZ · Aug 13, 2018 · Radiology

Device Facts

Record ID	K181318
Device Name	ONIS-PACS
Applicant	Digitalcore Co., Ltd.
Product Code	LLZ · Radiology
Decision Date	Aug 13, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	Software as a Medical Device

Intended Use

ONIS-PACS is a software device intended to be used by healthcare personnel and intended for viewing, reviewing, performing measurements/quantifications and reporting of medical images and data acquired from DICOM compliant medical imaging systems. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy images and digitized film images must not be used for primary diagnosis or interpretation.

Device Story

ONIS-PACS is a DICOM 3.0-compliant software system for storage, retrieval, visualization, and analysis of medical images. Components include ONIS Viewer (desktop visualization/processing), Local Server (background DICOM communication), ONIS Remote (client-only viewer), WebONIS (ActiveX browser-based viewer), ONIS Site Server (storage/retrieval), and ONIS Organization Server (multi-site access). Input consists of DICOM objects from imaging modalities; processed via workstation or network-distributed servers. Features include 2D/3D visualization, multi-planar reconstruction (MPR), maximum intensity projection (MIP), volume rendering, annotation, and measurement tools. Used in clinical settings by healthcare personnel for diagnostic support and reporting. Output includes displayed images, quantitative measurements, and reports. Benefits include centralized image management and standardized review workflows.

Clinical Evidence

No clinical data. Bench testing only. Software verification and validation testing performed to demonstrate safety and effectiveness for a moderate level of concern device.

Technological Characteristics

Software-only PACS; DICOM 3.0 compliant. Operates on Windows 7, 8, 10, and Windows Server 2008/2012. Supports 2D, mammography, MPR, MIP, and volume rendering. Connectivity via standard DICOM protocols. Includes annotation and measurement tools. No hardware components.

Indications for Use

Indicated for healthcare personnel to view, review, measure, quantify, and report medical images and data from DICOM-compliant imaging systems. Contraindicated for primary diagnosis or interpretation using lossy or digitized film images.

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

iQ-System PACS (K062488)

Related Devices

K082269 — VISAGE PACS, VERSION 6.0/CS 3.1 · Visage Imaging, Inc. · Dec 12, 2008
K062490 — VISAGE PACS/CS, RELEASE VERSION 4.1 · Mercury Computer Systems, Inc. · Oct 27, 2006
K160108 — Synapse PACS · Fujifilm Medical Systems U.S.A, Inc. · Feb 3, 2016
K052545 — INFINITT G3 PACS · Infinitt Co., Ltd. · Nov 8, 2005
K160315 — I4 (Integrated Intelligent Imaging Informatics) system · Philips Medical Systems Nederland B.V. · Feb 19, 2016

Submission Summary (Full Text)

{0}------------------------------------------------ August 13, 2018 Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. DigitalCore Co., Ltd % Esin Yesilalan Senior Regulatory Scientist Voisin Consulting, Inc. 222 Third St. Suite 3121 CAMBRIDGE MA 02142 Re: K181318 Trade/Device Name: Onis-Pacs Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: May 17, 2018 Received: May 18, 2018 Dear Esin Yesilalan: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801; medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices {1}------------------------------------------------ or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to 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, Michael D. O'Hara 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) K181318 Device Name ONIS-PACS #### Indications for Use (Describe) ONIS-PACS is a software device intended to be used by healthcare personnel and intended for viewing, reviewing, performing measurements/quantifications and reporting of medical images and data acquired from DICOM compliant medical imaging systems. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy images and digitized film images must not be used for primary diagnosis or interpretation. | Type of Use (Select one or both, as applicable) | | |-----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------| | ☑ 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}------------------------------------------------ # 510(k) SUMMARY ### I. Submitter Information | Company Name: | DigitalCore Co.,ltd | |--------------------------------|-----------------------------------------------------------------------------------------------------------------------| | Company Address: | Setagaya-ku Kinuta 5-8-31 Ginga-M2 157-0073 Tokyo, Japan | | Company Phone: | Tel: +81 (3) 5727-1064 | | Company Fax: | +81 (3) 5727-1065 | | Contact Person: | Cedric Lemoigne, DigitalCore Director cedric@dgcore.co.jp +81-90-5335-8104 (Japan) +33-7-68-58-52-25 (France) | | Date the summary was prepared: | August 7, 2018 | ## II. Device Identification | Trade Name: | ONIS-PACS | |----------------------|--------------------------------------------| | Common Name: | Picture Archiving and Communication System | | Classification Name: | System, Image Processing, Radiological | | Product Code: | LLZ | | Regulation Number: | 892.2050 | | Device Class: | Class II | #### III.Identification of Predicate Devices | Device Name | iQ-System PACS | |------------------|--------------------------------------------| | Manufacturer | IMAGE Information Systems Ltd | | 510(k) Number | K062488 | | Regulatory Class | Class II | | Common Name | Picture Archiving and Communication System | | Clearance Date | Sep 19 2006 | ## IV. Device Description ONIS-PACS is a Picture Archiving Communication System (PACS) fully compliant with the DICOM version 3.0 Standard. It is suitable for storing, distributing, retrieving, visualizing, manipulating, performing measurements/quantifications and reporting various DICOM objects. {4}------------------------------------------------ ONIS Viewer is a desktop application that makes it possible to visualize, manipulate and process medical images of many different modalities. Basic and advanced tools are provided for manipulating and processing images, including multi-planar reconstruction and 3D volume rendering. The software also includes a Local Server service running in the background that can send and receive DICOM images and can respond to DICOM queries. The ONIS Viewer and the Local Server applications must run on the same computer. ONIS Remote is a desktop application identical to the ONIS Viewer, except that it runs without the Local Server. It must connect to a Site Server to retrieve the studies to be retrieved and processed. WebONIS is an ActiveX component loaded into an HTML page that provides the same functionality as the ONIS Remote application. It can only be used with the Microsoft Internet Explorer browser. The browser must connect to a web server to load the ActiveX component, and the latter then connects directly to an ONIS Site Server or an ONIS Organization Server. ONIS Site Server is a server application that supports the storage and retrieval of a wide range of DICOM Storage objects. It also supports the storage and retrieval of graphical annotations and reports when connected to ONIS client applications (ONIS Viewer, ONIS Remote, and WebONIS). ONIS Organization Server is a server that provides a single access point to multiple Site Servers. ### V. Indications for Use ONIS-PACS is a software device intended to be used by healthcare personnel and intended for viewing, reviewing, performing measurements/quantifications and reporting of medical images and data acquired from DICOM compliant medical imaging systems. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy images and digitized film images must not be used for primary diagnosis or interpretation. #### VI. Comparison to Predicate Devices | Device Name | New Device | Predicate Device | Comparison | |-------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | DigitalCore | IMAGE Information Systems Ltd | - | | 510(k) Number | To be assigned | K062488 | - | | Regulatory Class | Class II | Class II | EQUIVALENT | | Regulation Number | 21 CFR 892.2050 | 21 CFR 892.2050 | EQUIVALENT | | Product Code | LLZ | LLZ | EQUIVALENT | | Device Name | New Device | Predicate Device | Comparison | | Common Name | Picture Archiving Communications System | Picture Archiving Communications System | EQUIVALENT | | Clearance Date | To be assigned | Sep 19 2006 | - | | Indications for Use | ONIS-PACS is a software device intended to be used by healthcare personnel and intended for viewing, reviewing, performing measurements/quantific ations and reporting of medical images and data acquired from DICOM compliant medical imaging systems. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy images and digitized film images must not be used for primary diagnosis or interpretation. | iQ-System PACS is a software device intended for viewing of images acquired from CT, MR, CR, DR, US and other DICOM compliant medical 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. It is the User's responsibility to ensure monitor quality, ambient light conditions, and image compression ratios are consistent with clinical application. | EQUIVALENT - Both devices are software only devices intended to allow clinicians to view and process DICOM images, and communicate results over a network. Both devices provide support for mammographic images, and both devices contra- indicate that lossy images should not be used for primary diagnosis nor interpretation. | | Prescription device | YES | YES | EQUIVALENT | | Environment of Use | Prescription device, intended for use in a healthcare setting | Prescription device, intended for use in a healthcare setting | EQUIVALENT | | Technological characteristics | | | | | System Architecture | Software only device, comprises workstation and web software, as well as server software. | Software only device, comprises workstation and web software, as well as server software. | EQUIVALENT | | Operating System | Windows 7, 8, 10 Microsoft Windows 2008 Server Standard Microsoft Windows 2012 Server Standard | Windows 2000 / XP | EQUIVALENT - The subject device works on newer versions of the same Microsoft Windows Operating System | | Device Name | New Device | Predicate Device | Comparison | | Data Access and Communication | Accesses DICOM data on removable media (USB drive, optical disk), local and network drives, and also accesses DICOM data from DICOM server applications using DICOM communication protocols | Accesses DICOM data from portable media as well as through server applications using DICOM communication protocols | EQUIVALENT - Both device access data using Standard DICOM protocols | | Image file import | YES | YES | EQUIVALENT | | Patient CD/DVD import | YES | YES | EQUIVALENT | | Export to a portable memory | YES, Export to memory stick, optical media | YES , Export to memory stick | EQUIVALENT | | Image export to image file or AVI video file | YES | YES | EQUIVALENT | | Mammography Display | YES | YES | EQUIVALENT | | Image Visualization | Supports 2D, Mammography, Multi Planar Reconstruction (Axial, Sagittal, Coronal, Oblique, Double Oblique), Maximum Intensity Projection and Volume Rendered views | Supports mammography display, Orthogonal and Oblique Multi Planar Reconstruction, Maximum Intensity Projection, Surface Shaded Display and Volume Rendered views | EQUIVALENT - Both devices support standard image and volume rendering views | | Support for Hanging Protocols | YES | YES | EQUIVALENT | | Annotation Tools | Supports text, arrow, angle, line and other user drawn region of interest shapes | Support for standard annotation tools | EQUIVALENT - Both devices provide standard annotation tools | | Measurement Tools | Supports distance and angle measurements, and pixel statistics for user drawn regions of interest | Supports advanced measurement tools including Region of Interest computations | EQUIVALENT - Both devices provide standard measurement tools | | Image Manipulation Tools (Window width/level, Pan, Zoom, etc.) | Provides tools for window width/level, pan, zoom, rotate, color LUT, opacity table, image filters | Provides tools for window width/level, pan, zoom, rotate, image filters, volume cropping and clipping, and other volume rendering color, transparency and light setting options | EQUIVALENT - Both devices provide standard image manipulation functionality | | Data Output | Supports export of images to various image formats, and printing of images and reports. | Supports export of secondary capture images to the local imagebox, filesystem or PACS | EQUIVALENT - Both devices support export of images to multiple destinations | | Device Name | New Device | Predicate Device | Comparison | | Review report | YES (HTML format) | YES (SR formats) | EQUIVALENT - Both devices support report generation functionality, though the specific report format may be different | | Windows print | YES | YES | EQUIVALENT | | JPEG lossy/lossless compression | YES | YES | EQUIVALENT | | Edit patient demographics | YES | YES | EQUIVALENT - Both devices allow for edit of patient demographics. ONIS-PACS implements technical controls to ensure that only authorized users can make these modifications. | | DICOM Query/ Retrieve, DICOM Print | YES | YES | EQUIVALENT | The table below summarizes the comparison between the ONIS-PACS and the iQ-System. {5}------------------------------------------------ {6}------------------------------------------------ {7}------------------------------------------------ Both ONIS-PACS and the predicate device have similar technological characteristics, and any differences are only related to the specific software implementation. #### VII. Performance Testing Like the predicate device. ONIS-PACS is a software only medical device. The ONIS- PACS was determined to present a moderate level of concern per the FDA guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 11, 2005". Software Validation and Verification testing was performed on the ONIS-PACS device to demonstrate safety and effectiveness. #### VIII. Conclusion The subject device has the same intended use as the predicate device, and differences in technological characteristics do not raise different questions of safety and effectiveness. On this basis, ONIS-PACS is substantially equivalent to the legally marketed predicate device.