(120 days)
K063337, KO31562, KO23557
Not Found
No
The document describes standard PACS viewer functionalities like viewing, manipulation, annotation, and hanging protocols, with no mention of AI or ML capabilities.
No.
The device description indicates it is a PACS viewer for displaying and manipulating medical images, not for directly treating or diagnosing patients. Its function is to view and organize data, which is a supportive rather than a therapeutic function.
No
The Communify PACS Viewer is described as a software application for viewing, manipulating, and organizing DICOM images and data. Its purpose is to facilitate the review of medical images by qualified personnel, not to provide a diagnosis itself.
Yes
The device is described as a "software application" that runs on "standard 'off-the-shelf' personal computers, business computers, and servers". The description focuses entirely on the software's functionalities for viewing, manipulating, and managing medical images, without mentioning any proprietary hardware components included with the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Communify PACS Viewer is designed to view, manipulate, and manage medical images from various modalities (CR, CT, MR, etc.). It facilitates the organization, display, and basic manipulation of these images for review by qualified personnel.
- Device Description: The description focuses on the software's capabilities related to image display, manipulation (zoom, pan, etc.), annotation, and organization.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not interact with biological specimens or perform any analysis on them.
The Communify PACS Viewer is a medical image management and viewing system, which falls under a different regulatory category than IVD devices.
N/A
Intended Use / Indications for Use
The Communify PACS Viewer is an image display software application that is intended for use by qualified physicians and other personnel for reading, diagnostic review, and analysis of digital images acquired from imaging devices such as CT, MR, CR, DX, MG, US, NM, PET, and other devices. The Communify PACS Viewer is a Picture Archiving and Communications System (PACS) viewer designed to be used to view Digital Imaging and Communications in Media (DICOM) and non-DICOM information and data.
The Communify PACS Viewer is an image display software application that accepts DICOM data from any OEM modality which supports DICOM standard imaging data; the system provides the capability to organize images generated by OEM vendor equipment, perform digital manipulation, create graphical representations of anatomical areas, and perform quantitative measurements.
The Communify PACS Viewer is a Picture Archiving and Communications System (PACS) viewer designed to be used to view Digital Imaging and Communications in Media (DICOM) and non-DICOM information and data. The Communify PACS Viewer is a software application that runs on standard "offthe-shelf" personal computers, business computers, and servers running . standard operating systems. Communify PACS Viewer is an image and display software that accepts DICOM data from any OEM modality which supports DICOM standard imaging data; the system provides the capability to organize images generated by OEM vendor equipment, perform digital manipulations, create graphical representations of anatomical areas, and perform quantitative measurements.
Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
The Communify PACS Viewer is an application which allows users to view, manipulate, annotate, transmit to other facilities, print, and animate all manner of DICOM images and modalities. These modalities include, but are not limited to, CR, CT, DX, MR, NM, PT, RF, US, and XA.
The Communify PACS Viewer contains common image manipulation functions (such as zoom, pan, triangulation, and window/level) and common image labeling tools (including measurements tools, drawing tools, and annotation overlays). The annotation overlay displays all the important metadata (as configured by the user) for each displayed series study. Although annotation fields depend on the modality and the patient study, the Annotation Overlay Template Wizard provides a full list of annotation fields that the user can assign into the image display.
For easy access to tools and features, there are shortcut keys, toolbars, and right-click menus.
The Hanging Protocol editor of the Communify PACS Viewer configures the presentation layout of images on the screen when a study is loaded. This allows commonly used display formats and presets to be saved and easily accessed to allow for faster case study reviews.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CR, CT, DX, MR, NM, PT, RF, US, XA, MG, PET
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified physicians and other personnel
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)
Not Found
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.
K063337, KO31562, KO23557
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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5. 510(k) Summary (21 CFR 807.92)
JUL 20 2011
"This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92."
"The assigned 510(k) number is: K)//0 717
| Submitter's name: | Christopher Relyea |
|---|---|
| Submitter's address: | 160 West 71st Street, 18th Floor, New York, NY 10023 |
| USA | |
| Phone number: | 646-526-7111 |
| Fax number: | 203-621-3198 |
| Name of contact person: | Christopher Relyea |
| Date the summary was prepared: | 02/23/2011 |
| Device Name/Trade Name: | Communify PACS Viewer |
| Common Name: | Medical Image Workstation |
| Classification Name: | 21 CFR 892.2050 |
| Product Code | LLZ |
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Substantially equivalent to the devices are the following:
| Manufacturer | Device | 510(k) |
|---|---|---|
| Viztek, Inc. | Opal-RAD | K063337 |
| RamSoft, Inc. | RamSoft PACS | KO31562 |
| General Electric Medical Systems | Centricity PACS Plus | KO23557 |
Comparison to Predicate Devices
The similarity of Communify PACS Viewer with the predicate devices listed above is that they all are or contain PACS Viewer systems. They can all process and display medical images from DICOM compliant modalities such as CR, CT, DX, MR, NM, PT, RF, US, XA, and others.
Most of the tools, features, and settings in the PACS Viewers are commonly available across Communify PACS Viewer and the predicate devices listed above. Each device, including Communify PACS Viewer, has its own slightly unique interface, but someone familiar with any of the devices should be able to use any other device without difficulty.
Conclusion
The Communify PACS Viewer meets its intended use and design specifications for a picture archiving and communications system viewer. It has the required capabilities relating to the transfer, display, and digital processing of medical images. It is our conclusion that Communify PACS Viewer is significantly comparable to the PACS Viewers within Opal-RAD, RamSoft PACS, and Centricity PACS Plus.
Device Description
The Communify PACS Viewer is an application which allows users to view, manipulate,
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annotate, transmit to other facilities, print, and animate all manner of DICOM images and modalities. These modalities include, but are not limited to, CR, CT, DX, MR, NM, PT, RF, US, and XA.
The Communify PACS Viewer contains common image manipulation functions (such as zoom, pan, triangulation, and window/level) and common image labeling tools (including measurements tools, drawing tools, and annotation overlays). The annotation overlay displays all the important metadata (as configured by the user) for each displayed series study. Although annotation fields depend on the modality and the patient study, the Annotation Overlay Template Wizard provides a full list of annotation fields that the user can assign into the image display.
For easy access to tools and features, there are shortcut keys, toolbars, and right-click menus.
The Hanging Protocol editor of the Communify PACS Viewer configures the presentation layout of images on the screen when a study is loaded. This allows commonly used display formats and presets to be saved and easily accessed to allow for faster case study reviews.
Intended Use Statement
The Communify PACS Viewer is an image display software application that is intended for use by qualified physicians and other personnel for reading, diagnostic review, and analysis of digital images acquired from imaging devices such as CT, MR, CR, DX, MG, US, NM, PET, and other devices. The Communify PACS Viewer is a Picture Archiving and Communications System (PACS) viewer designed to be used to view Digital Imaging and Communications in Media (DICOM) and non-DICOM information and data.
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The Communify PACS Viewer is an image display software application that accepts DICOM data from any OEM modality which supports DICOM standard imaging data; the system provides the capability to organize images generated by OEM vendor equipment, perform digital manipulation, create graphical representations of anatomical areas, and perform quantitative measurements.
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Image /page/4/Picture/0 description: The image shows a logo for the Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings and body. The text "DEPARTMENT OF HEALTH &" is vertically oriented and curves around the left side of the logo.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Chris Relyca CEO Flying Squirrel Storage LLC 160 West 71st Street, 18th Floor NEW YORK NY 10023
JUL 20 2011
Re: K110797
Trade/Device Name: Communify PACS Viewer Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 2, 2011 Received: July 7, 2011
Dear Mr. Relyca:
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Mary S Pastel
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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4. Indications for Use Statement
510(k) Number (if known): K II0 797 Device Name: Communify PACS Viewer
Indications for Use:
The Communify PACS Viewer is a Picture Archiving and Communications System (PACS) viewer designed to be used to view Digital Imaging and Communications in Media (DICOM) and non-DICOM information and data. The Communify PACS Viewer is a software application that runs on standard "offthe-shelf" personal computers, business computers, and servers running . standard operating systems. Communify PACS Viewer is an image and display software that accepts DICOM data from any OEM modality which supports DICOM standard imaging data; the system provides the capability to organize images generated by OEM vendor equipment, perform digital manipulations, create graphical representations of anatomical areas, and perform quantitative measurements.
Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images.
Prescription Use _X
Mary S. Patel
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
K110797
510K
、 Over-The-Counter Use
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(Part 21 CFR 801 Subpart D) AND/OR (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)