Retrospective patient imaging studies were used to validate the diagnostic image quality of the Vitrea View software for mammography and digital breast tomosynthesis by comparing it against cleared predicate systems.
Retrospective clinical data; Image quality validation; Diagnostic mammography; Digital breast tomosynthesis
Clinical Evidence
Study Design
Population
Comparator
Key Endpoints
Multi-reader, multi-case retrospective validation study; Study Period: Two-day time-frame
Existing patient studies from a breast imaging center; Sample Size: 50 studies; Number of Sites: 1
McKesson Radiology system (K140909)
Image quality equivalence (7-point scale)
Multi-reader, multi-case retrospective validation study
Existing patient studies from a breast imaging center; Sample Size: 50 studies; Number of Sites: 1
Phillips Intellispace Radiology system (K111804)
Image quality equivalence (7-point scale)
Indications for Use
Vitrea View software is a medical image viewing and information application that provides access, through the internet and within the enterprise to multi-modality softcopy medical images (including mammography and digital breast tomosynthesis), reports, and other patient-related information. This data is hosted within disparate archives and repositories for diagnosis, review, communication, and reporting of DICOM and non-DICOM data. Lossy compressed mammography images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA cleared display that meets technical specifications reviewed and accepted by FDA or displays accepted by the appropriate regulatory agency for the country in which it is used. Display monitors used for reading medical images for diagnostic purposes must comply with the applicable regulatory approvals and quality control requirements for their use and maintenance. Vitrea View software is indicated for use by qualified healthcare professionals including, but not restricted to, radiologists, non-radiology specialists, physicians and technologists. When accessing Vitrea View software from a mobile device, images viewed are for informational purposes only and not intended for diagnostic use.
Device Story
Vitrea View is a web-based, zero-footprint enterprise image viewer. It aggregates DICOM and non-DICOM medical images and reports from disparate archives (PACS, VNA) for access via standard internet browsers on PCs, Macs, and mobile devices. It supports multi-modality viewing, including mammography and digital breast tomosynthesis. Clinicians use the software for diagnostic review, collaboration, and treatment planning. Key features include 2D/3D/MPR viewing, measurement tools, and contextual EHR/EMR integration. The device facilitates clinical decision-making by providing diagnostic-quality image access at the point of care. It benefits patients by enabling rapid, enterprise-wide access to imaging data, fostering collaboration among specialists, and supporting efficient diagnostic workflows.
Clinical Evidence
No clinical studies required. Bench testing included multi-reader, multi-case validation studies comparing Vitrea View to cleared reference systems (McKesson Radiology K140909 and Phillips Intellispace K111804). Four radiologists evaluated 50 mammography studies and three radiologists evaluated 50 digital breast tomosynthesis studies. Metrics included visualization of tissue, contrast, sharpness, and artifacts. Results confirmed clinical equivalence for diagnostic quality.
Technological Characteristics
Web-based, zero-footprint software architecture using HTML and JavaScript. Supports DICOM and non-DICOM data. Connectivity via HTTPS/SSL. Compatible with standard internet browsers on Windows, Mac, iOS, and Android. Complies with DICOM (PS 3.1-3.20), ISO 14971:2007 (risk management), and IEC 62304:2006 (software lifecycle).
Indications for Use
Indicated for qualified healthcare professionals (radiologists, non-radiology specialists, physicians, technologists) to access, view, and report on multi-modality medical images (including mammography and digital breast tomosynthesis) and patient data for diagnosis and review. Not for primary interpretation of lossy compressed mammography or digitized film screen images. Mobile access is for informational purposes only, not diagnostic use.
Regulatory Classification
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.
Special Controls
*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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 21, 2017
Vital Images, Inc. % Fei Li Regulatory Affairs Specialist 5850 Opus Parkway, Suite 300 MINNETONKA MN 55343
Re: K163232 Trade/Device Name: Vitrea View Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 14, 2017 Received: June 15, 2017
Dear Fei Li:
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. 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
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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,
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) K163232
Device Name Vitrea View
#### Indications for Use (Describe)
Vitrea View software is a medical image viewing and information distribution that provides access, through the internet and within the enterprise to multi-modality softcopy medical images (including mammography and digital breast tomosynthesis), reports, and other patient-related information. This data is hosted within disparate archives and repositories for diagnosis, review, communication, and reporting of DICOM and non-DICOM data.
Lossy compressed mammography images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA cleared display that meets technical specifications reviewed and accepted by FDA or displays accepted by the appropriate regulatory agency for the country in which it is used.
Display monitors used for reading medical images for diagnostic purposes must comply with the applicable regulatory approvals and quality control requirements for their use and maintenance.
Vitrea View software is indicated for use by qualified healthcare professionals including, but not restricted to. radiologists, non-radiology specialists, physicians and technologists.
When accessing Vitrea View software from a mobile device, images viewed are for informational purposes only and not intended for diagnostic use.
Type of Use (Select one or both, as applicable)
| <span style="font-family: Arial, sans-serif;"> <span style="font-size: 10pt;"> <span style="font-style: normal;"> <span style="font-variant-ligatures: normal;"> <span style="font-variant-caps: normal;"> <span style="font-weight: normal;"> <span style="letter-spacing: normal;"> <span style="orphans: 2;"> <span style="text-align:start;"> <span style="text-indent: 0px;"> <span style="text-transform: none;"> <span style="white-space: normal;"> <span style="widows: 2;"> <span style="word-spacing: 0px;"> <span style="display: inline !important;"> <span> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial, sans-serif;"> <span style="font-size: 10pt;"> <span style="font-style: normal;"> <span style="font-variant-ligatures: normal;"> <span style="font-variant-caps: normal;"> <span style="font-weight: normal;"> <span style="letter-spacing: normal;"> <span style="orphans: 2;"> <span style="text-align:start;"> <span style="text-indent: 0px;"> <span style="text-transform: none;"> <span style="white-space: normal;"> <span style="widows: 2;"> <span style="word-spacing: 0px;"> <span style="display: inline !important;"> <span> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> |
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# 510K Summary
This 510(k) summary is submitted in accordance with the requirements of 21 C.F.R. Part 807.92(c).
| Basis for the Submission: | Vital Images, Inc. hereby submits this traditional 510(k) to obtain<br>510(k) clearance for the Vitrea View software which we believe is<br>substantially equivalent to the FDA cleared VitreaView (K150738). |
|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Vital Images, Inc.<br>5850 Opus Parkway, Suite 300<br>Minnetonka, MN, 55343-4414 |
| Establishment Registration: | 2134213 |
| Contact Person: | Fei Li<br>Regulatory Affairs Specialist<br>Phone : 952-487-9539<br>Fax: 952-487-9510<br>E-mail: fli@vitalimages.com<br><br>Alternate Contact Person:<br>Vince Swenson<br>Sr. Director of Quality and Regulatory<br>Phone: 952-487-9548<br>Fax: 952-487-9510<br>E-mail: vswenson@vitalimages.com |
| 510(k) Type: | Traditional |
| Summary Date: | November 16, 2016 |
| Device Trade Name: | Vitrea View |
| Device Common Name/ Regulatory Description: | Picture Archiving and Communications System |
| Device Classification Name: | System, Image Processing, Radiological |
| Regulation Number: | 21 CFR 892.2050 |
| Product Code: | LLZ |
| Regulatory Classification: | Class II |
| Device Panel: | Radiology |
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## Predicate Device(s):
| Predicate Device | Manufacturer | FDA 510(k) Number |
|------------------|-------------------------------------------------------------------------------------------|-------------------|
| VitreaView | Vital Images, Inc.<br>5850 Opus Parkway, Suite 300,<br>Minnetonka, Minnesota 55343 U.S.A. | K150738 |
#### Reference Device(s):
| Reference Device | Manufacturer | FDA 510(k) Number |
|-------------------------------------------|-----------------------------------------------------------------------------------------|-------------------|
| McKesson Radiology | McKesson Medical Imaging Company<br>5995 Winward Parkway<br>Alpharetta, GA 30005 | K140909 |
| Phillips Intellispace<br>Radiology system | Philips Healthcare Informatics, Inc.<br>4100 E 3rd Ave Ste 101<br>Foster City, CA 94404 | K111804 |
## Device Description:
The Vitrea View software is a web-based, cross-platform, zero-footprint enterprise image viewer solution capable of displaying both DICOM and non-DICOM medical images. The Vitrea View software enables clinicians and other medical professionals to access patients' medical images with integrations into a variety of medical record systems, such as Electronic Health Record (EHR), Electronic Medical Record (EMR), Health Information Exchange (HIE), Personal Health Record (PHR), and image exchange systems. The Vitrea View software is a communication tool, which supports the physician in the treatment and planning process by delivering access to images at the point of care.
The Vitrea View software offers medical professionals an enterprise 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 install client systems, due to the web-based zero-footbrint nature of the Vitrea View software. The Virea View software offers scalability to add new users as demand grows, and may be deployed in a virtualized environment. Some of the general features include:
. Fast time-to-first-image
- Contextual launch integration with single-sign-on ●
- . Easy study navigation and search capability
- Supports multi-modality vendor-neutral DICOM images
- . Supports non-DICOM images
- lmages display at full diagnostic quality (with appropriate hardware) ●
- . Basic 2D review tools (zoom, pan, measure)
- Basic 3D and MPR viewing ●
- Radiology key images
- . Comparative side-by-side review, regardless of image types
- . Collaboration tools
- . Leverages traditional DICOM as well as next-generation DICOMweb image transfer protocols
- Enables federated access to across multiple data sources across multiple sites ●
- . Web-based zero-footprint architecture
- Secure Access on various Windows® and Mac computers through standard internet ● browsers
- . Secure Access on various iOS®, Android™, and Windows® tablet devices through the device's Internet browser
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- . Secure Access on various iOS and Android smartphones through the device's Internet browser
#### Intended Use / Indications for Use:
Vitrea View software is a medical image viewing and information application that provides access, through the internet and within the enterprise to multi-modality softcopy medical images (including mammography and digital breast tomosynthesis), reports, and other patient-related information. This data is hosted within disparate archives and repositories for diagnosis, review, communication, and reporting of DICOM and non-DICOM data.
Lossy compressed mammography images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA cleared display that meets technical specifications reviewed and accepted by FDA or displays accepted by the appropriate regulatory agency for the country in which it is used.
Display monitors used for reading medical images for diagnostic purposes must comply with the applicable requlatory approvals and quality control requirements for their use and maintenance.
Vitrea View software is indicated for use by qualified healthcare professionals including, but not restricted to, radiologists, non-radiology specialists, physicians and technologists.
When accessing Vitrea View software from a mobile device, images viewed are for informational purposes only and not intended for diagnostic use.
#### Intended for Disease / Condition / Patient Population:
Vitrea View software is a medical image viewer software. Therefore, specific information on the intended disease, condition, and patient population is not applicable.
#### Key Changes from the last 510(k) clearance K150738
Kev Changes include:
- Support for diagnostic viewing of mammographic images and digital breast tomography ● images
- . Enhancements in the administration and support of the product
- Ability to allow clinicians to collaborate on images, information, and artifacts related to the ● imaging studies using the Vitrea View software
- User Centric enhancements
- Performance Improvements
- Licensing enhancements
- Better integration with EMRs by supporting more targeted searchers within the launch and history search APIs
- . Ability to record information of users who accessed the Vitrea View software and which studies they viewed
- . Add support for Breast Tomography SOP class
- . Support for SQL Server 2014
- Improvements in connectivity to archives including PACS, VNA and DICOMWeb .
- . View the UDI for Vitrea View identification
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# ViTAL
# Substantial Equivalence Comparison:
# Regulatory Comparison:
| Characteristic | Subject Device | Predicate Device | |
|---------------------|------------------------------------------------------|------------------------------------------------------|--------------------------------|
| | Vitrea View | VitreaView<br>(K150738) | Comparison |
| Classification Name | Picture Archiving<br>and<br>Communications<br>System | Picture Archiving<br>and<br>Communications<br>System | Same |
| Regulatory Number | 892.2050 | 892.2050 | Same |
| Product Code | LLZ | LLZ | Same |
| Classification | Class II | Class II | Same |
| Review Panel | Radiology | Radiology | Same |
| Decision Date | TBD | April 6, 2015 | Predicate device is<br>cleared |
### Indications for Use Comparison with Predicate Device:
| | Subject Device | Predicate Device | | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Criteria | Vitrea View | VitreaView (K150738) | Comparison | |
| Indications for Use | Vitrea View software is<br>a medical image<br>viewing and<br>information distribution<br>application that<br>provides access,<br>through the internet<br>and within the<br>enterprise to multi-<br>modality softcopy<br>medical images<br>(including<br>mammography and<br>digital breast<br>tomosynthesis),<br>reports, and other<br>patient-related<br>information. This data<br>is hosted within<br>disparate archives and<br>repositories for<br>diagnosis, review,<br>communication, and<br>reporting of DICOM<br>and non-DICOM data. | VitreaView is a<br>medical image viewing<br>and information<br>distribution application<br>that provides access,<br>through the internet<br>and within the<br>enterprise to multi-<br>modality softcopy<br>medical images,<br>reports, and other<br>patient-related<br>information. This data<br>is hosted within<br>disparate archives and<br>repositories for<br>diagnosis, review,<br>communication, and<br>reporting of DICOM<br>and non-DICOM data.<br>Display monitors used<br>for reading medical<br>images for diagnostic<br>purposes must comply<br>with the applicable<br>regulatory approvals<br>and quality control | Similar<br>Added support for<br>Vitrea View to be used<br>for diagnostic viewing<br>of mammographic<br>images and digital<br>breast tomography<br>images | |
| | Lossy compressed<br>mammography | | | |
| Criteria | Subject Device | Predicate Device | Comparison | |
| | Vitrea View | VitreaView (K150738) | | |
| | images and digitized<br>film screen images<br>must not be reviewed<br>for primary image<br>interpretations.<br>Mammographic<br>images may only be<br>interpreted using an<br>FDA cleared display<br>that meets technical<br>specifications<br>reviewed and<br>accepted by FDA or<br>displays accepted by<br>the appropriate<br>regulatory agency for<br>the country in which it<br>is used.<br>Display monitors used<br>for reading medical<br>images for diagnostic<br>purposes must comply<br>with the applicable<br>regulatory approvals<br>and quality control<br>requirements for their<br>use and maintenance.<br>Vitrea View software is<br>indicated for use by<br>qualified healthcare<br>professionals<br>including, but not<br>restricted to,<br>radiologists, non-<br>radiology specialists,<br>physicians and<br>technologists.<br>When accessing<br>Vitrea View software<br>from a mobile device,<br>images viewed are for<br>informational purposes<br>only and not intended<br>for diagnostic use. | requirements for their<br>use and maintenance.<br>Lossy compressed<br>mammography<br>images and digitized<br>film screen images<br>must not be reviewed<br>for primary image<br>interpretations.<br>When accessing<br>VitreaView from a<br>mobile device, images<br>viewed are for<br>informational purposes<br>only and not intended<br>for diagnostic use. | | |
| Intended Users | Qualified healthcare<br>professionals<br>including, but not<br>restricted to, | Qualified healthcare<br>professionals<br>including, but not<br>restricted to, | Same | |
| Criteria | Subject Device | Predicate Device | Comparison | |
| | Vitrea View | Vitrea View (K150738) | | |
| | radiologists, non-<br>radiology specialists,<br>physicians and<br>technologists. | radiologists, non-<br>radiology specialists,<br>physicians and<br>technologists. | | |
| Patient Population | Vitrea View software is<br>a medical image<br>viewer software.<br>Therefore, specific<br>information on the<br>intended disease,<br>condition, and patient<br>population is not<br>applicable. | VitreaView is a<br>medical image viewer<br>software. Therefore,<br>specific information on<br>the intended disease,<br>condition, and patient<br>population is not<br>applicable. | Same | |
| Modality Support | Multi-modality | Multi-modality | Same | |
| Criteria | Description | Subject Device<br>Vitrea View | Predicate Device<br>VitreaView<br>(K150738) | Comparison |
| Annotation and<br>Measurement<br>Tools | • Line<br>• Angle<br>• Ruler<br>• Arrow | Yes | Yes | Same |
| User Installation<br>Requirements | • Runs within browser<br>using HTML and<br>JavaScript only<br>• No installation is<br>required on user's<br>machine | Yes | Yes | Same |
| Data Type<br>Supported | • DICOM<br>• Non-DICOM | Yes | Yes | Same |
| Image View/<br>Manipulation | • Image Zoom<br>• Pan<br>• Window Level<br>• Auto Window<br>Level<br>• Reset<br>• Scout Lines<br>• Image Rotate<br>• Image Flip<br>• Magnify<br>• Image Invert<br>• Image Cine | Yes | Yes | Same |
| Data Encryption | • HTTPS<br>• SSL | Yes | Yes | Same |
| Patient<br>Demographic<br>Display | Capable of displaying<br>patient demographic<br>information | Yes | Yes | Same |
| Linking | Co-planar linking:<br>• Autolink<br>• Manual | Yes | Yes | Same |
| User and<br>Password<br>Control | Users can be managed<br>via an internal<br>database, active<br>directory, or parent<br>application | Yes | Yes | Same |
| Data Security<br>Audit Trail | Stored on server<br>Audit trail logged | Yes<br>Yes | Yes<br>Yes | Same<br>Same |
| Criteria | Description | Subject Device<br>Vitrea View | Predicate Device<br>Vitrea View<br>(K150738) | Comparison |
| User<br>Management | Database structure<br>allows mapping users to<br>groups internally or<br>mapping external<br>groups (AD, parent<br>application) to internal<br>groups and role | Yes | Yes | Same |
| Transmission<br>Modes | Via the web with<br>Internet browsers | Yes | Yes…
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Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.