(122 days)
Not Found
No
The summary describes a standard PACS software for viewing and managing medical images. There is no mention of AI, ML, or any features that would typically utilize these technologies for image analysis, processing beyond basic viewing functions, or decision support. The description focuses on image display, storage, communication, and basic manipulation (windowing, zoom, pan, etc.).
No
The device is a PACS (Picture Archiving and Communication System) software designed to display and manage medical images for diagnostic purposes. It does not provide any direct therapy or treatment to patients.
Yes
The device is described as a PACS software that allows trained professionals (like physicians and radiologists) to interpret images for primary image diagnosis, which is a diagnostic activity.
Yes
The device description explicitly states "INFINITT ULite, PACS is a software device" and details its functions as software components (Viewer and Server) running on standard computer operating systems. It does not mention or include any proprietary hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- This device is a PACS (Picture Archiving and Communication System) software. Its primary function is to receive, store, communicate, process, and display medical images (like X-rays, CT scans, MRIs, mammograms) and associated data.
- The intended use and device description clearly focus on handling and displaying medical images, not on analyzing biological specimens.
Therefore, while it's a medical device used in diagnosis, it falls under the category of medical imaging software rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
INFINITT ULite, PACS is a software device that receives medical images and data from various images. Images and data can be stored, communicated, processed, and displayed within the system or across computer networks at distributed locations. Only preprocessed DICOM for presentation images can be interpreted for primary image diagnosis in mammography.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary inage interpretations. Mammographic images may only be interpreted using a monitor that meets technical specification identified by FDA. Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, and medical technicians.
Product codes
LLZ
Device Description
The INFINITT ULIte™ system is PACS software capable of viewing and handling DICOM 3.1 medical images. The System allows displaying studies that are not in the same place where the system is placed. With its Web features, it is possible to review, modify, and approve studies located in a server.
ULite is a device that displays medical images (including mammograms) and data from various imaging sources. In the Web environments, it is not needed to download any components, for example Active X, flash, flex, sliver lite, and the user can use this viewer in the browser. Typical users of this system are professionals of clinic (e.g. physicians, radiologists, nurses, medical technicians, and assistants).
INFINITT ULite (subject device) is based upon the INFINITT G3 PACS (predicate device). The features and functions of ULite have a sub-set of the features and functions of G3 PACS with an updated operating system due to current advances in computer technology.
INFINITT ULite Viewer: INFINITT ULite is a medical image viewing application. It communicates with the INFINITT ULite Server to view the medical images. It supports various functions such as Windowing, Zoom, Pan, measurement, Cine play, and Report viewing.
INFINITT ULite Server: INFINITT ULite Server only supports Microsoft Windows family INFINITT ULite Server has been built by using Microsoft Visual C++ 2010, MFC library and .net framework.
ULite software provides both 32-bit and 64-bit editions. When running on x64 editions of Microsoft Windows, the native x64-bit application of ULite must be provided for largememory support. The 32-bit application of ULite can be running on both 32bit and 64bit windows, while the maximum memory capacity might be different. Except the maximum memory support, the 32-bit edition and 64-bit edition must be virtually same in terms of functionalities.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Medical images and data from various imaging sources. Specifically mentions mammographic images.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained professionals, e.g. physicians, radiologists, nurses, and medical technicians. Professionals of clinic (e.g. physicians, radiologists, nurses, medical technicians, and assistants).
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)
The complete system configuration has been tested at the factory and the device has passed all in-house pre-determined testing criteria without significant failures. The data presented in the submission demonstrates that INFINITT ULite™ performs all required actions according to the functional requirements specified in the Software Requirements Specification and the User Manual with no errors that had an impact on safety or efficacy.
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).
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 24, 2017
INFINITT Co., Ltd. INFINITT Healthcare Corporation % Mr. Carl Alletto Consultant OTech Inc. 8317 Belew Drive MCKINNEY TX 75071
Re: K163290
Trade/Device Name: INFINITT ULite Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 14, 2016 Received: November 22, 2016
Dear Mr. Alletto:
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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D'Hara
For
Robert 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) K163290
Device Name INFINITT ULite
Indications for Use (Describe)
INFINITT ULite, PACS is a software device that receives medical images and data from various images. Images and data can be stored, communicated, processed, and displayed within the system or across computer networks at distributed locations. Only preprocessed DICOM for presentation images can be interpreted for primary image diagnosis in mammography.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary inage interpretations. Mammographic images may only be interpreted using a monitor that meets technical specification identified by FDA. Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, and medical technicians.
| 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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3
This 510(k) Summary of Safety and Effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
Date Prepared:
November 14, 2016
Submitter's Information: 21 CFR 807.92(a)(1) Mr. Sang Wook Cho Chief Quality Officer, Research and Development Center, INFINITT Healthcare Corporation 12FI Daerung Post Tower III, 27 Digital-ro 34th Street Guro-gu, Seoul 152-746, South Korea Fax +82-2-3663-8426
Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2)
| Trade Name: | INFINITT ULite™ |
|---|---|
| Common Name: | Picture Archiving Communications System |
| Device Classification: | 892.2050 System, Image Processing |
| Product Code: | LLZ |
Predicate Device: 21 CFR 807. 92(a)(3)
| Device Classification Name | system, image processing, radiological |
|---|---|
| 510(k) Number | K052545 |
| Device Name | INFINITT G3 PACS |
| Applicant | INFINITT CO., LTD. |
| Regulation Number | 892.2050 |
| Classification Product Code | LLZ |
| Date Received | 09/15/2005 |
| Decision Date | 11/08/2005 |
| Decision | substantially equivalent (SE) |
| Regulation Medical Specialty | Radiology |
| 510k Review Panel | Radiology |
| summary | summary |
| Type | Traditional |
| Reviewed by Third Party | No |
| Combination Product | No |
Device Description: 21 CFR 807 92(a)(4)
The INFINITT ULIte™ system is PACS software capable of viewing and handling DICOM 3.1 medical images. The System allows displaying studies that are not in the same place where the system is placed. With its Web features, it is possible to review, modify, and approve studies located in a server.
ULite is a device that displays medical images (including mammograms) and data from various imaging sources. In the Web environments, it is not needed to download any components, for example Active X, flash, flex, sliver lite, and the user can use this viewer
4
510(k) Summary of Safety and Effectiveness
in the browser. Typical users of this system are professionals of clinic (e.g. physicians, radiologists, nurses, medical technicians, and assistants).
INFINITT ULite (subject device) is based upon the INFINITT G3 PACS (predicate device). The features and functions of ULite have a sub-set of the features and functions of G3 PACS with an updated operating system due to current advances in computer technology.
| INFINITT
ULite
Viewer | INFINITT ULIte is a medical image viewing application.
It communicates with the INFINITT ULite Server to view the medical
images. It supports various functions such as Windowing, Zoom, Pan,
measurement, Cine play, and Report viewing. |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| INFINITT
ULite
Server | INFINITT ULite Server only supports Microsoft Windows family
INFINITT ULite Server has been built by using Microsoft Visual C++
2010, MFC library and .net framework. |
ULite software provides both 32-bit and 64-bit editions. When running on x64 editions of Microsoft Windows, the native x64-bit application of ULite must be provided for largememory support. The 32-bit application of ULite can be running on both 32bit and 64bit windows, while the maximum memory capacity might be different. Except the maximum memory support, the 32-bit edition and 64-bit edition must be virtually same in terms of functionalities.
Indications for Use: 21 CFR 807 92(a)(5)
INFINITT ULite. PACS is a software device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, processed, and displayed within the system or across computer networks at distributed locations. Only preprocessed DICOM for presentation images can be interpreted for primary image diagnosis in mammography.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using a monitor that meets technical specification identified by FDA. Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, and medical technicians.
Technological Characteristics: 21 CFR 807 92(a)(6)
INFINITT ULite™ device is a software product that handles digital medical images. The device does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed.
Testing
The complete system configuration has been tested at the factory and the device has passed all in-house pre-determined testing criteria without significant failures. The data presented in the submission demonstrates that INFINITT ULite™ performs all required actions according to the functional requirements specified in the Software Requirements Specification and the User Manual with no errors that had an impact on safety or efficacy.
Conclusion: 21 CFR 807 92(b)(1)
The 510 (k) Pre-Market Notification for INFINITT ULite™ contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device. INFINITT ULIte™ has been and will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey. The submission contains the results of a hazard analysis and the "Level of Concern for potential hazards has been classified as "Moderate".