(155 days)
Not Found
No
The summary describes standard PACS functionality (image storage, retrieval, display, processing, measurement) and does not mention AI, ML, or related terms. The "image processing" mentioned is likely standard digital image manipulation, not AI-driven analysis.
No
The device is an image management system (PACS) used for storing, processing, and displaying medical images for diagnostic purposes. It does not directly treat or diagnose a disease or condition.
No
The device is an image management system (PACS) for receiving, storing, distributing, processing, and displaying medical images. While it supports viewing for diagnosis, it does not perform diagnostic functions itself; rather, it provides the tools for trained professionals to make a diagnosis using the images.
Yes
The device is described as a "software package" and a "software solution" consisting of two software components. While it interacts with general purpose computing hardware and receives data from imaging modalities, the device itself is solely the software. The description does not indicate the inclusion of any proprietary or specific hardware components as part of the device submission.
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 (like blood, urine, or tissue) to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- ExamVue PACS Function: ExamVue PACS is an image management system. Its primary function is to receive, store, distribute, process, and display medical images (specifically from CR and DX modalities) for viewing and diagnosis by trained professionals. It does not perform any tests on biological samples.
- Intended Use: The intended use clearly states it's for managing and displaying images, not for performing diagnostic tests on patient samples.
- Device Description: The description focuses on software components for image handling and viewing, not on laboratory testing or analysis of biological materials.
Therefore, ExamVue PACS falls under the category of medical imaging software or a Picture Archiving and Communication System (PACS), not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Exam Vue PACS is an image management system intended to be used by trained professionals, including physicians, radiologists, nurses and medical technicians.
The software is a software package used with general purpose computing hardware to receive, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, communication and storage. This device is not indicated for use in mammography.
ExamVue PACS supports receiving, sending, printing, storing and displaying studies received from the following modality types via DICOM: CR and DX.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
The ExamVue PACS is a software solution for the storage, sharing, display and viewing for diagnosis of medical images. It consists of two software components, a central database and server software that holds, receives and distributes images, and a viewer program that can be installed on multiple computers for viewing. modifying, making measurements on, and displaying the images in the database.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CR and DX
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained professionals, including physicians, radiologists, nurses and medical technicians.
Clinical environment.
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)
Safety testing and documentation was performed in accordance with IEEE 1012-2012, Standard for System and Software Verification and Validation.
Software Verification and Validation documentation for ExamVue PACS, as well as bench and clinical testing, have been provided in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is written in a sans-serif font.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 17, 2017
JPI Healthcare Solutions, Inc. % Mr. William Little Product Manager 52 Newtown Plaza PLAINVIEW NY 11803
Re: K162868 Trade/Device Name: Exam Vue PACS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 3, 2017 Received: March 7, 2017
Dear Mr. Little:
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
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Indications for Use
510(k) Number (if known) K162868
Device Name ExamVue PACS
Indications for Use (Describe)
Exam Vue PACS is an image management system intended to be used by trained professionals, including physicians, radiologists, nurses and medical technicians.
The software is a software package used with general purpose computing hardware to receive, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, communication and storage. This device is not indicated for use in mammography.
ExamVue PACS supports receiving, sending, printing, storing and displaying studies received from the following modality types via DICOM: CR and DX.
| 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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510 (k) Summary
February 28th, 2017.
-
- Company and Correspondant Making the Submission:
Name: JPI Healthcare Co., LTD Address: Woolim e-BIZ center #608 170-5, Kuro-3-dong, Kuro-gu Seoul, 152-769 Telephone: +82-2-2108 - 2580 (Ext. 500-504) Fax: +82-2-2108-1180 Contact: John Lim Website: http://www.jpi.co.kr/
- Company and Correspondant Making the Submission:
-
- Identification of Device
| Classification Name: | Imaging Processing System, Radiological |
|---|---|
| Common Name: | Picture Archiving and Communication System (PACS) |
| Trade/Proprietary Name: | ExamVue PACS |
3. Predicate Device
| Manufacturer: | Vieworks Co, Ltd |
|---|---|
| Device: | QXLink |
| 510(k) Number: | K092081 |
| Classification Name: | Imaging Processing System, Radiological |
| Common Name: | Picture Archiving and Communication System (PACS) |
| Regulatory Number: | 21 CFR 892.2050 |
| Regulatory Class: | II |
| Product Code: | 90 LLZ |
| Manufacturer: | Televere |
|---|---|
| Device: | Tigerview Professional |
| 510(k) Number: | K061035 |
| Classification Name: | Imaging Processing System, Radiological |
| Common Name: | Picture Archiving and Communication System (PACS) |
| Regulatory Number: | 21 CFR 892.2050 |
| Regulatory Class: | II |
| Product Code: | 90 LLZ |
4
- Product Classification Names and Citations 4.
| Classification Name: | Imaging Processing System, Radiological |
|---|---|
| Common Name: | Picture Archiving and Communication System (PACS) |
| Regulatory Number: | 21 CFR 892.2050 |
| Regulatory Class: | II |
| Product Code: | 90 LLZ |
న్. Description:
The ExamVue PACS is a software solution for the storage, sharing, display and viewing for diagnosis of medical images. It consists of two software components, a central database and server software that holds, receives and distributes images, and a viewer program that can be installed on multiple computers for viewing. modifying, making measurements on, and displaying the images in the database.
-
- Indication for use
ExamVue PACS is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians.
- Indication for use
The software is a software package used with general purpose computing hardware to receive, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, communication and storage. This device is not indicated for use in mammography.
ExamVue PACS supports receiving, sending, printing, storing and displaying studies received from the following modality type via DICOM: CR and DX.
-
- Comparison with Predicate Device:
JPI Healthcare Co., Ltd, believes that the ExamVue PACS is substantially equivalent to the predicate devices, TigerView Professional and QXLink
- Comparison with Predicate Device:
All three devices have the same basic structure (a central server database and associated viewers), function (the storage, display and diagnosis of DICOM images) and follow the DICOM protocol. They have similar intended uses, and provide similar suites of tools to fulfil their function.
The ExamVue PACS differs from the predicate devices is user interface and compatible operating systems. We believe this does not represent a substantial difference between the two devices, as the change in system requirements reflect the change in computer technology since the release of the predicate device, and the user interface presents the same essential data and supports similar workflow as the predicate device.
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8. Safety, EMC and Performance Data
Safety testing and documentation was performed in accordance with IEEE 1012-2012, Standard for System and Software Verification and Validation.
Software Verification and Validation documentation for ExamVue PACS, as well as bench and clinical testing, have been provided in this submission.
-
- Conclusions:
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification JPI Healthcare Co., Ltd. concludes that ExamVue PACS is safe and effective and substantially equivalent to predicate devices as described herein.
- Conclusions:
A detailed comparison supporting this conclusion can be found in Exhibit 1, Substantial Equivalence Chart below.
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EXHIBIT 1
SUBSTANTIAL EQUIVALENCE CHART
| Characteristics | ExamVue PACS | TigerView
Professional | QXLink |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | JPI Healthcare
Solutions, Inc | Televere Systems | Vieworks Co, Ltd |
| 510K Number | K162868 | K001035 | K092081 |
| Intended use. | ExamVue PACS is
an image
management system
intended to be used
by trained
professionals,
including
physicians,
radiologists, nurses
and medical
technicians.
The software is a
software package
used with general
purpose computing
hardware to receive,
store, distribute,
process and display
images and
associated data
throughout a
clinical
environment. The
software performs
digital image
processing,
measurement,
communication and
storage. This device
is not indicated for
use in
mammography.
ExamVue PACS
supports receiving,
sending, printing, | TigerView
Professional is a
clinical software
application that
receives images and
data from various
imaging sources
(eg., radiographic
devices, digital
video capture
device, and generic
image devices such
as scanners). In
addition, TigerView
Professional
enables the storage
of clinical notes and
clinical exam data.
It is intended to
acquire, display,
edit(e.g., resize,
adjust contrast,
crop, annotate, etc.),
review, store, print,
and distribute
images using
standard PC
hardware | The QXLink is a
device that provides
one or more
capabilities relating to
the acceptance,
transfer, display,
storage, and digital
processing of medical
images. The software
components provide
functions for
performing operations
related to image
manipulation,
enhancement, or
quantification.DICOM
3.0 standard. It can
transfer images
processed in
PACS and print
images with a film
printer compatible
with DICOM 3.0 by
using DICOM and
Network systems. |
| | storing and
displaying studies
received from the
following modality
types via DICOM:
CR and DX. | | |
| Performance Standard | 21 CFR 892.2050 | 21 CFR 892.2050 | 21 CFR 892.2050 |
| Operating System
Requirements | Windows 7 or
Windows 8 or
Windows 10 | Windows Based
Operating Systems | Windows Based
Operating Systems |
| Image Archive | Yes | Yes | Yes |
| Image Transfer | (DICOM 3.0
Standard) | (DICOM 3.0
Standard) | (DICOM 3.0
Standard) |
| Image Display | Yes | Yes | Yes |
| Patient Search | Yes | Yes | Yes |
| Distance and
Angle
Measurements | Yes | Yes | Yes |
| Window Level
Adjustment | Yes | Yes | Yes |
| Zoom and
Magnify Functions | Yes | Yes | Yes |
| Line Profile and
Histogram | Yes | Yes | Yes |
| DICOM Directory
Reading | Yes | No | Yes |
| DICOM
Query/Retrieve | Yes | No | Yes |
| DICOM Import | Yes | Yes | Yes |
| DICOM CD Burn | Yes | Yes | Yes |
| DICOM Print | Yes | Yes | Yes |
| DICOM Tag | Yes | Yes | Yes |
| Display
Patient
Information
Editing | Yes | Yes | Yes |
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The intended use and environment of the device is the same as the predicate devices, with only minor differences in features that are not integral to the function of the device. For this reason, we believe it is substantially equivalent to the predicate devices.