(87 days)
No
The document describes a standard PACS system with image viewing, manipulation, and storage capabilities, without mentioning any AI or ML features.
No
The device is a software for viewing, processing, and managing medical images, not for directly treating a disease or condition.
No.
The device is described as a Picture Archiving Communication System (PACS) intended for viewing, reviewing, performing measurements/quantifications, and reporting of medical images. While it processes and displays medical images, its primary stated function is not to provide a diagnosis or aid in diagnostic decision-making directly. There is no mention of diagnostic algorithms, AI, or specific diagnostic outputs. It is a tool for managing and visualizing existing medical images.
Yes
The device description explicitly states "ONIS-PACS is a software device" and details various software components (Viewer, Local Server, Remote, WebONIS, Site Server, Organization Server) that handle medical images and data. There is 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:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- ONIS-PACS Functionality: The description clearly states that ONIS-PACS is a software device for viewing, reviewing, measuring, and reporting on medical images acquired from DICOM compliant medical imaging systems. It deals with images generated by modalities like CT, MR, etc., not with analyzing biological samples.
The device's purpose is to manage and display medical images for diagnostic interpretation by healthcare personnel, which falls under the category of medical imaging software, not in vitro diagnostics.
N/A
Intended Use / 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.
Product codes
LLZ
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.
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.
Mentions image processing
Yes, "process medical images of many different modalities."
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
DICOM compliant medical imaging systems (e.g., CT, MR, CR, DR, US)
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare personnel (Prescription Use), healthcare setting
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)
Software Validation and Verification testing was performed on the ONIS-PACS device to demonstrate safety and effectiveness.
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
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).
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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
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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) |
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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.
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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.
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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.