(18 days)
Not Found
No
The document describes standard image viewing, manipulation, and 3D reconstruction capabilities, but does not mention AI, ML, or related terms.
No
The device is described as a display and analysis tool for diagnostic images, and it does not mention any therapeutic function or intention to treat a condition.
Yes
The "Intended Use / Indications for Use" section states: "The xViewNet software is intended as a display and analysis tool for the interpretation of diagnostic images by trained healthcare professionals..." This explicitly indicates its use in the diagnostic process.
Yes
The device description explicitly states "This software-based product" and mentions using "standard 'off-the-shelf' PC hardware" and "standard TCP/IP stack," indicating the device itself is the software component running on general-purpose hardware.
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. They are used to provide information for diagnosis, monitoring, or screening.
- xViewNet's Function: xViewNet is described as a software for displaying, analyzing, and managing diagnostic images. These images are acquired from various imaging modalities (CR, CT, MR, etc.) which are external to the body. The software processes and presents these images for interpretation by healthcare professionals.
- No Mention of Biological Samples: The description of xViewNet does not mention any interaction with or analysis of biological samples from the human body. Its input is image data, not biological specimens.
Therefore, xViewNet falls under the category of medical imaging software or a Picture Archiving and Communication System (PACS) component, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The xViewNet software is intended as a display and analysis tool for the interpretation of diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended to provide access to covered entities for clinical review, throughout the healthcare facility and at the point of image acquisition. This device is not intended for mammography use.
xViewNet is a secured imaging software system that receives medical images and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations.
This device is not intended for mammography use.
Product codes
LLZ
Device Description
x ViewNet is a secured imaging system that is used to view, edit, manipulate, annotate, analyze, and store images and data that are stored and managed in the web-based RIS. This software-based product provides capabilities for the acceptance, transmission, printing, display, storage, editing and digital processing of medical images and associated data.
Images sent to xViewNet are converted into formats suitable for viewing in its framework, and temporarily stored in a local cache memory. The algorithms used by xViewNet to view JPEG and JPEG 2000 images follow known and acceptable protocols. Changes may be made to the presentation of the images. These changes are saved as display definitions only and do not alter the acquired image pixel data. Any and all display definitions applied to an image can always be reversed to the acquired state.
The xViewNet software includes advanced visualization such as 3-D multiplanar reconstruction of the 2-D images.
x ViewNet uses standard "off-the-shelf" PC hardware and communicates using the standard TCP/IP stack. The network hardware used to support the TCP/IP stack is superfluous to XViewNet.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
DICOM 3.0 file specification, including all standard classes and modalities (CR, CT, MR, NM, US, RF, SC, VL, etc.)
Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended to provide access to covered entities for clinical review, throughout the healthcare facility and at the point of image acquisition.
Description of the training set, sample size, data source, and annotation protocol
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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 xViewNet program complies with the voluntary standards as detailed in Section 9 of this submission.
The following quality assurance measures were applied to the development of the MedViewNet program:
- Risk Analysis
- Requirements Reviews
- Design Reviews
- Testing on unit level (Module Verification)
- Integration testing (System Verification)
- Final Acceptance Testing (Validation)
- Performance Testing
- Safety Testing
American Radiologist Network certifies that the x ViewNet software is designed, developed, tested and validated according to written procedures. These procedures identify individuals within the organization responsible for developing and approving product specifications, coding and testing, validation testing and field maintenance.
For details please see Section 16. Software, item 7. Verification & Validation Testing.
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).
0
Image /page/0/Picture/1 description: The image is a circular seal with text around the perimeter. The text reads "American Radiological Moducet AMRADHET". In the center of the seal is a symbol that looks like a stylized medical or scientific emblem. The emblem consists of a central design with smaller, similar shapes arranged around it.
510(k) Summary (per 21 CFR 807.92)
FEB
22
2000
I. Applicant: American Radiologist Network, Inc. 2298 N.W. 60th Street Boca Raton, FL. 33496, U.S.A
Neil Iyer, President & CEO Contact Person: Tel: 805-906-1360 Fax: 805-520-0568 e-mail: neil@amradnet.com
II. Device Name
Proprietary Name: xViewNet Picture Archiving and Communications System Common/ Usual Name: Classification Name: System, Image Processing, Radiological Regulation Number: 892.2050 LLZ Product Code: 2 Classification:
III. Predicate Device
The xViewNet PACS is substantially equivalent to the following predicate devices:
IV. Intended Use of the Device
The xViewNet software is intended as a display and analysis tool for the interpretation of diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended to provide access to covered entities for clinical review, throughout the healthcare facility and at the point of image acquisition.
This device is not intended for mammography use
V. Description of the Device
x ViewNet is a secured imaging system that is used to view, edit, manipulate, annotate, analyze, and store images and data that are stored and managed in the web-based RIS. This software-based product provides capabilities for the
1
Image /page/1/Picture/0 description: The image is a circular emblem or seal with text around the perimeter. The text reads "AMERICAN RADIOLOGIST NETWORK" at the top and "ZMRADKEY" at the bottom. In the center of the emblem, there is a symbol that appears to be a stylized image of a medical device or tool, repeated in a pattern. The emblem has a vintage or slightly distressed appearance, with some areas of the image appearing faded or worn.
acceptance, transmission, printing, display, storage, editing and digital processing of medical images and associated data.
Images sent to xViewNet are converted into formats suitable for viewing in its framework, and temporarily stored in a local cache memory. The algorithms used by xViewNet to view JPEG and JPEG 2000 images follow known and acceptable protocols. Changes may be made to the presentation of the images. These changes are saved as display definitions only and do not alter the acquired image pixel data. Any and all display definitions applied to an image can always be reversed to the acquired state.
The xViewNet software includes advanced visualization such as 3-D multiplanar reconstruction of the 2-D images.
x ViewNet uses standard "off-the-shelf" PC hardware and communicates using the standard TCP/IP stack. The network hardware used to support the TCP/IP stack is superfluous to XViewNet.
VI. Technical Characteristics
- Support for the DICOM 3.0 file specification, including all standard . classes and modalities (CR, CT, MR, NM, US, RF, SC, VL, etc.)
- Overview of study or series with different filter possibilities t
- Interactive scrolling through picture series .
- Thumbnail view of different picture series .
- Tools freely configurable to the different mouse buttons .
- Interactive change of W/L or W/C .
- Picture zoom with pixel interpolation ●
- Magnifying glass .
- Panning of pictures .
- Shows modality-dependent DICOM header information in each picture .
- Placing and show values of grey tones (numeric), distances and angles . (graphic and numeric), text annotations, ellipses, polygons, and arrows
- Several picture series can be shown side by side .
- Allocation of picture by free layout choice .
- Turn picture, reflect picture and invert picture .
- Fast Interactive 3D volume rendering .
- Coronal, Axial and Sagittal views .
- x ViewNet is able to read and display the HUGO dataset .
- Fast continuous looping display of images in a series (cine-loop) at . various speeds: forwards, backwards, and bi-directional
2
Image /page/2/Picture/0 description: The image is a circular seal with text around the perimeter. The text reads "American Bildtological Institute Zinradnet". In the center of the seal is a symbol that appears to be a stylized representation of a screw or bolt, with four smaller symbols resembling screws or bolts arranged around it.
- Linking and Unlinking of windows to coordinate actions (window/level, . panning, zooming, etc)
VII. Testing
The xViewNet program complies with the voluntary standards as detailed in Section 9 of this submission.
The following quality assurance measures were applied to the development of the MedViewNet program:
- Risk Analysis .
- Requirements Reviews .
- Design Reviews .
- Testing on unit level (Module Verification) .
- Integration testing (System Verification) .
- Final Acceptance Testing (Validation) .
- Performance Testing .
- Safety Testing .
American Radiologist Network certifies that the x ViewNet software is designed, developed, tested and validated according to written procedures. These procedures identify individuals within the organization responsible for developing and approving product specifications, coding and testing, validation testing and field maintenance.
For details please see Section 16. Software, item 7. Verification & Validation Testing.
VIII. Safety and Effectiveness
There are no substantial differences between the xViewNet defined in this 510(k) submission and the stated predicate devices. They are similar to the technologies that are currently used in other similar medical devices.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
FEB 22 2008
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
American Radiologist Network, Incorporated % Mr. James W. Monroe Staff Engineer -- Medical Devices Intertek Testing Services NA, Incorporated 2307 East Aurora Road Unit B7 TWINSBURG OH 44087
Re: K080290
Trade/Device Name: xViewNet PACS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 1, 2008 Received: February 4, 2008
Dear Mr. Monroe:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.
Image /page/3/Picture/10 description: The image is a circular logo with the letters "FDA" in large, bold font in the center. Above the letters, the numbers "1906-2006" are printed. Below the letters, the word "Centennial" is written in cursive. The logo is surrounded by a circular border with text and stars. The text is difficult to read due to the image quality.
Protecting and Promoting Public Health
4
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.
Sincerely vours.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/5/Picture/0 description: The image is a circular emblem or seal with text around the perimeter. The text reads "PUNJAB RAJYA BIJLI BOARD AMRADHET". In the center of the emblem is a stylized design that includes geometric shapes, possibly representing electrical components or a power grid. The design is symmetrical and appears to be a logo for an organization related to electricity or power in the Punjab region.
510(k) Number (if known):
Device Name: xViewNet
Indications for Use:
xViewNet is a secured imaging software system that receives medical images and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations.
This device is not intended for mammography use
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Agni De Whas
(Division Sign-Off Division of Reproductive, Abdomina and Radiological Devic 510(k) Number
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