(260 days)
Not Found
No
The document describes a mobile client for viewing, processing, and archiving medical images. It focuses on basic image manipulation (zoom, pan, window level) and access to a server. There is no mention of AI, ML, or any advanced analytical capabilities that would typically involve these technologies. The performance studies focus on basic viewing functions compared to predicate devices.
No
The device is described as a mobile client for diagnostic image viewing, review, display, and archiving, clearly stating it is not intended for therapeutic decisions.
Yes
The device explicitly states its intended use for "diagnostic image viewing of radiological images" and that it "may support physicians and/or the medical staff by providing mobile access to relevant medical images" for diagnostic decisions. While it clarifies it's not meant to replace full reading workstations or be used for primary diagnosis in certain cases, its core function is for viewing images for diagnostic purposes.
Yes
The device is described as a "mobile client" and "app" that runs on mobile devices with a touch screen. It accesses images remotely from a server and provides viewing and manipulation functionalities. There is no mention of accompanying hardware components that are part of the medical device itself.
Based on the provided text, Visage Ease Pro is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: IVD devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Visage Ease Pro's Function: Visage Ease Pro is a mobile client for viewing and reviewing radiological images (Xray, CT, MRI, etc.). These images are generated by medical imaging equipment and are not specimens taken from the body.
- Intended Use: The intended use clearly states it's for "diagnostic image viewing of radiological images" and "image review by clinicians." It is not used to analyze biological samples.
Therefore, Visage Ease Pro falls under the category of medical imaging software or a Picture Archiving and Communication System (PACS) client, not an IVD.
N/A
Intended Use / Indications for Use
Visage Ease Pro is a mobile client for diagnostic image viewing of radiological images from the following modalities: Xray, CT, MRI, PET, SPECT, Ultrasound and XA. It is based on the Visage 7 product for distributing, viewing, processing, and archiving medical images within and outside health care environments.
Visage Ease Pro must only be used by trained health care professionals. It may support physicians and/or the medical staff by providing mobile access to relevant medical images. Any diagnostic decision resides with the doctors and/or the medical staff in their respective area of responsibility.
Visage Ease Pro is not intended to replace full radiologic reading workstations. It must not be used in the context of diagnostic or therapeutic decisions if a radiologic reading workstation with appropriate display hardware is available. The user must make sure that the reading environment complicable diagnostic requirements and the state-of-the-art.
Visage Ease Pro must not be used for primary image diagnosis in mammography or digital breast tomosynthesis.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
Visage Ease Pro is a mobile client for diagnostic image viewing of radiological images, image review by clinicians and image display for illustration and educational purposes. It is based on the Visage 7 product for distributing, viewing, processing, and archiving medical images within and outside health care environments.
Visage Ease Pro has a graphical user interface which is optimized for mobile devices with a touch screen. The app allows searching for studies and viewing images and reports. The user may zoom and pan images, adjust the window level, browse through a stack of images or play a cine animation. Patient and image information is displayed as viewer text. The app supports voice memos, image attachments and push notifications.
Visage Ease Pro is designed as a thin client in a single module and allows to remotely access the images on a Visage 7 server. The communication between the mobile client and the server is encrypted. The user must authenticate himself with username and password. A connection can only be established, if the user has the appropriate permissions for using the mobile client. These permissions are configurable on the Visage 7 server.
Mentions image processing
Yes
Mentions AI, DNN, or ML
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Input Imaging Modality
Xray, CT, MRI, PET, SPECT, Ultrasound and XA
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained health care professionals
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)
Visage Ease Pro is clinically validated against predicate devices. The clinical validation focuses on primary operating functions for clinical use cases. Visage Ease Pro is clinically validated against the predicate devices Visage 7® and Mobile MIM™
The primary operating functions covered by the clinical validation are loading of images, selecting a series of images, adjusting the window level, zooming and panning an image, browsing through a stack of images, and playing cine animations.
The data sets for the modalities CT, CR, DX, MRI, PET, SPECT, US, and XA are viewed with the predicate devices and Visage Ease Pro.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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 is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 28, 2015
Visage Imaging GmbH % Mr. Stefan Strowich Manager of Quality Systems and Regulatory Affairs Lepsiustrasse 70 Berlin 12163 GERMANY
Re: K142196 Trade/Device Name: Visage Ease Pro Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 11, 2015 Received: February 12, 2015
Dear Mr. Strowich:
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,
Robert A Ochs
Robert Ochs. Ph.D. Acting 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) K142196
Device Name Visage Ease Pro
Indications for Use (Describe)
Visage Ease Pro is a mobile client for diagnostic image viewing of radiological images from the following modalities: Xray, CT, MRI, PET, SPECT, Ultrasound and XA. It is based on the Visage 7 product for distributing, viewing, processing, and archiving medical images within and outside health care environments.
Visage Ease Pro must only be used by trained health care professionals. It may support physicians and/or the medical staff by providing mobile access to relevant medical images. Any diagnostic decision resides with the doctors and/or the medical staff in their respective area of responsibility.
Visage Ease Pro is not intended to replace full radiologic reading workstations. It must not be used in the context of diagnostic or therapeutic decisions if a radiologic reading workstation with appropriate display hardware is available. The user must make sure that the reading environment complicable diagnostic requirements and the state-ofthe-art.
Visage Ease Pro must not be used for primary image diagnosis in mammography or digital breast tomosynthesis.
| 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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Image /page/3/Picture/0 description: The image shows the logo for Visage Imaging. The logo consists of a green and gray geometric shape on the top left, with the words "Visage Imaging" in black font to the right of the shape. The word "Imaging" is in bold font, and there is a registered trademark symbol after the word.
510(k) Summary of Safety and Effectiveness
In accordance with the requirements of the Safe Medical Device Act, Visage Imaging GmbH herewith submits a Summary of Safety and Effectiveness. This 510(k) summary for the Visage Ease Pro meets the requirements of 21 CFR 807.92.
| Submitter Information: | Visage Imaging GmbH
Lepsiusstrasse 70
12163 Berlin
Germany
Phone: +49 30 700968 41
Fax: +49 30 700968 11
Registration Number: 9616251
Owner/Operator Number: 9040273 |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Correspondent: | Stefan Strowich
Visage Imaging GmbH
Lepsiusstrasse 70
12163 Berlin
Germany
Phone: +49 30 70096841
Fax: +49 30 70096811
E-Mail: sstrowich@visageimaging.com |
| US Agent (Contact): | Brad Levin
Visage Imaging, Inc.
12250 El Camino Real, Suite 230
San Diego, California, 92130, United States
Phone: +1 703 8585758
Fax: +1 858 4082717
E-mail: blevin@visageimaging.com |
| Date Prepared: | August 04st, 2014 |
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Image /page/4/Picture/0 description: The image shows the logo for Visage Imaging. The logo consists of a geometric shape in the upper left corner, with green and gray colors. The text "Visage Imaging" is written in a bold, sans-serif font below the geometric shape. The word "Imaging" has a trademark symbol next to it.
Device(s) Identification:
| Device Trade Name: | Visage Ease Pro |
|---|---|
| Release Version: | 1.5 |
| Device Classification Name: | System, Image Processing, Radiological |
| Regulation Description: | Picture archiving and communications system |
| Product Code: | LLZ |
| Reference: | per 21 CFR 892.2050 |
| Review Panel: | Radiology |
| Device Class: | II |
Device Description:
Visage Ease Pro is a mobile client for diagnostic image viewing of radiological images, image review by clinicians and image display for illustration and educational purposes. It is based on the Visage 7 product for distributing, viewing, processing, and archiving medical images within and outside health care environments.
Visage Ease Pro has a graphical user interface which is optimized for mobile devices with a touch screen. The app allows searching for studies and viewing images and reports. The user may zoom and pan images, adjust the window level, browse through a stack of images or play a cine animation. Patient and image information is displayed as viewer text. The app supports voice memos, image attachments and push notifications.
Visage Ease Pro is designed as a thin client in a single module and allows to remotely access the images on a Visage 7 server. The communication between the mobile client and the server is encrypted. The user must authenticate himself with username and password. A connection can only be established, if the user has the appropriate permissions for using the mobile client. These permissions are configurable on the Visage 7 server.
Intended Use:
Visage Ease Pro is a mobile client for diagnostic image viewing of radiological images, image review by clinicians and image display for illustration and educational purposes. It is based on the Visage 7 product for distributing, viewing, processing, and archiving medical images within and outside health care environments (cf. Intended Use - Visage 7 [1]).
Visage Ease Pro must only be used by trained health care professionals. It may support physicians and/or the medical staff by providing mobile access to relevant medical images. Any diagnostic or therapeutic decision resides with the doctors and/or the medical staff in their respective area of responsibility.
Visage Ease Pro must not be used in the context of diagnostic or therapeutic decisions if a radiologic reading workstation with appropriate display hardware is available. The user must make sure that the reading environment complies with any applicable diagnostic requirements and the state-of-the-art.
Visage Ease Pro must not be used for primary image diagnosis in mammography.
5
Image /page/5/Picture/0 description: The image shows the logo for Visage Imaging. The logo consists of a geometric shape in the upper left corner, with green and gray colors. The text "Visage Imaging" is written in a serif font below the geometric shape. The word "Imaging" has a trademark symbol next to it.
Visage Imaging GmbH Lepsiusstrasse 70 12163 Berlin Germany
Predicate devices:
| 1.
Device Trade Name:
Applicant:
510(k) No.: | Visage PACS 6.0 / CS 3.1 (Visage 7)
Visage Imaging, INC.
K082269 |
|-------------------------------------------------------|------------------------------------------------------------------------|
| 2.
Device Trade Name:
Applicant:
510(k) No.: | Mobile MIM (RT)
MIM Software Inc.
K112930 |
The Visage Ease Pro is considered substantial equivalent to the Visage PACS 6.0 / CS 3.1 (K082269), Mobile MIM (RT) (K112930).
Intended use, medical application and treatment method as well as the basic parameter settings are equivalent for the Visage Ease Pro, the Visage PACS 6.0 / CS 3.1 and the Mobile MIM (RT).
Summary of Technological Characteristics
The relevant clinical functions and technological characteristics of Visage Ease Pro are also included in the Mobile MIM (RT) software. The typical work flow is very similar for both devices. Both software devices show an identical behavior and would lead to the same diagnosis. Visage Ease Pro did not have any additional clinical functionality in comparison to Visage 7.
Summary of testing:
Visage Ease Pro is clinically validated against predicate devices. The clinical validation focuses on primary operating functions for clinical use cases. Visage Ease Pro is clinically validated against the predicate devices Visage 7® and Mobile MIM™
The primary operating functions covered by the clinical validation are loading of images, selecting a series of images, adjusting the window level, zooming and panning an image, browsing through a stack of images, and playing cine animations.
The data sets for the modalities CT, CR, DX, MRI, PET, SPECT, US, and XA are viewed with the predicate devices and Visage Ease Pro.
Conclusion:
Visage Imaging GmbH believes that the Visage Ease Pro is substantially equivalent to the currently legally marketed devices. The Visage Ease Pro does not introduce new indications for use, have the same technological characteristics and does not introduce new potential hazards or safety risks.