(23 days)
No Reference Device(s) were found in the text.
No
The document describes a medical image viewer with basic functionalities and integrations, but there is no mention of AI or ML technologies being used for image analysis, processing beyond basic tools, or any other function.
No
The device is described as a medical image viewing and information application for review, communication, and reporting of medical images and patient information, not for directly treating or diagnosing conditions, which defines a therapeutic device.
No
The "Intended Use / Indications for Use" section explicitly states, "VitreaView is not intended for primary diagnosis."
Yes
The device description explicitly states it is a "zero-footprint universal image viewer solution" and emphasizes its software-based nature with features like cross-browser, cross-platform capabilities, and integration with existing systems without requiring client installation. While it interacts with medical images and potentially hardware (monitors), the device itself is described solely as software.
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.
- VitreaView's Function: VitreaView is described as a medical image viewing and information application. Its primary function is to display and provide access to medical images (DICOM and non-DICOM) and related patient information. It is explicitly stated that it is "not intended for primary diagnosis."
- No Biological Sample Analysis: There is no mention of VitreaView analyzing biological samples or performing any tests on bodily fluids or tissues. Its input is medical images and patient data.
Therefore, VitreaView falls under the category of medical image viewing software, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
VitreaView is a medical image viewing and information application that provides access, through the Internet and within the enterprise, to multi-modality softcopy medical images, reports and other patient-related information, that may be hosted within disparate archives and repositories for review, communication and reporting of DICOM and non-DICOM data. VitreaView is not intended for primary diagnosis.
Display monitors used for reading medical images for diagnostic purposes must comply with applicable regulatory approvals and with quality control requirements for their use and maintenance.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by FDA.
Product codes
LLZ
Device Description
VitreaView is a cross-browser, cross-platform zero-footprint universal image viewer solution capable of displaying both DICOM and non-DICOM medical images. VitreaView enables referring clinicians and other medical professionals with access to patients' medical images in a seamless way, with integrations into their Electronic Health Record (EHR), Electronic Medical Record (EMR), and Health Information Exchange (HIE).
VitreaView offers medical professionals a universal viewer for accessing imaging data in context with reports from enterprise patient health information databases, fosters collaboration, and provides workflows and interfaces appropriate for referring physicians and clinicians. IT departments will not have to incur time to install client systems, due to the zero-footprint, zero download nature of VitreaView. VitreaView offers scalability to add new users as demand grows, may be deployed in a virtualized environment, and is designed to be integrated with enterprise patient health information databases.
Some of the general features include:
- 2D multi-modality review of data .
- . Basic 2D review tools (zoom, pan, measure)
- Easy study navigation .
- Comparative review .
- Displays of DICOM and non-DICOM images .
- A scalable, virtualizable infrastructure .
- Cross-platform viewing capabilities (Windows, Mac OS, etc.) .
- Leveraging of next-generation protocols for image viewing (i.e. MINT) .
- Single sign-on . .
- EMR integration ●
Mentions image processing
Radiological Image Processing Software
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
multi-modality softcopy medical images, DICOM and non-DICOM data
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
referring clinicians and other medical 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)
The software was designed, developed and tested according to written procedures. Software testing was completed to insure the new feature function according to the requirements and interacts without impact to existing functionality. The test results support a determination of substantial equivalence.
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).
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SUMMARY OF SAFETY AND EFFECTIVE USE
510(k) Number: K|||892
JUL 2 8 2011
Date Prepared: 31 May 2011
Submitter Information
| Submitter: | Vital Images, Inc. |
|---|---|
| Street Address: | 5850 Opus Parkway Suite 300 |
| Minnetonka, MN 55343-4414 | |
| Establishment registration: | 2134213 |
| Owner/Operator #: | 9024582 |
| Contact Person: | Ian Nemerov |
| Vice President, General Counsel & | |
| Secretary | |
| Phone: | (952) 487-9622 |
| Fax: | (952) 487-9510 |
| Email: | inemerov@vitalimages.com |
Device Information
| Trade Name | VitreaView |
|---|---|
| Common Name | Radiological Image Processing Software |
| Classification Name | System, Image Processing, Radiological |
| Regulation /Product Code | 21 CFR 892.2050 |
| Product Code | LLZ |
| Regulatory Classification: | Class II |
| Device Panel: | Radiology |
VitreaView is substantially equivalent to the previously-cleared, web-based software Cedara WebAccess™
Predicate Device
| Predicate Device | Manufacturer | FDA 510(k) |
|---|---|---|
| Cedara WebAccess™ | Cedara Software Corp. | |
| Mississauga, Ontario, Canada | K092915 |
Device Description
VitreaView is a cross-browser, cross-platform zero-footprint universal image viewer solution capable of displaying both DICOM and non-DICOM medical images. VitreaView enables referring clinicians and other medical professionals with access to patients' medical images in a seamless way, with integrations into their Electronic Health Record (EHR), Electronic Medical Record (EMR), and Health Information Exchange (HIE)
VitreaView offers medical professionals a universal viewer for accessing imaging data in context with reports from enterprise patient health information databases, fosters collaboration, and provides workflows and interfaces appropriate for referring physicians and clinicians. IT departments will not have to incur time to install client systems, due to the zero-footprint, zero
1
download nature of VitreaView. VitreaView offers scalability to add new users as demand grows, may be deployed in a virtualized environment, and is designed to be integrated with enterprise patient health information databases.
Some of the general features include:
- 2D multi-modality review of data .
- . Basic 2D review tools (zoom, pan, measure)
- Easy study navigation .
- Comparative review .
- Displays of DICOM and non-DICOM images .
- A scalable, virtualizable infrastructure .
- Cross-platform viewing capabilities (Windows, Mac OS, etc.) .
- Leveraging of next-generation protocols for image viewing (i.e. MINT) .
- Single sign-on . .
- EMR integration ●
Intended Use/Indications for Use
VitreaView is a medical image viewing and information application that provides access, through the Internet and within the enterprise, to multi-modality softcopy medical images, reports and other patient-related information, that may be hosted within disparate archives and repositories for review, communication and reporting of DICOM and non-DICOM data. VitreaView is not intended for primary diagnosis.
Display monitors used for reading medical images for diagnostic purposes must comply with applicable regulatory approvals and with quality control requirements for their use and maintenance.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by FDA.
Summary of Testing
The software was designed, developed and tested according to written procedures. Software testing was completed to insure the new feature function according to the requirements and interacts without impact to existing functionality. The test results support a determination of substantial equivalence.
Conclusions
VitreaView has similar indications for use as the predicate device and essentially identical technological characteristics. Minor feature differences do not raise any new questions regarding safety or effectiveness of the device. The VitreaView software performs as intended, and presents no unacceptable risks to the intended patient population or end user. VitreaView is substantially equivalent to the predicate device.
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo includes a symbol on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The symbol appears to be a stylized representation of a human figure or a caduceus. The text is in a clear, sans-serif font and is horizontally aligned.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring. MD 20993-0002
Vital Images, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
JUL 28 2011
Re: K111892
Trade/Device Name: VitreaView Regulation Number: 21 CFR 892.2050 Regulation Name: Picture arching and communications system Regulatory Class: II Product Code: LLZ Dated: July 1, 2011 Received: July 5, 2011
Dear Mr. Job:
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 of
3
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 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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Indications for Use
510(k) number (if known) (