VitreaAdvanced is a medical diagnostic system for the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. VitreaAdvanced is not meant for primary image interpretation in mammography. It can be used with a variety of cleared Vitrea® based software applications. In addition, VitreaAdvanced includes three Vitrea applications:

Vitrea® CT Body Perfusion is a noninvasive post-processing application designed to evaluate perfusion of organs and tumors. The software can calculate perfusion characteristics from dynamic CT image data acquired after the injection of contrast media. The software also allows the separate calculation of the arterial and venous components of perfusion in organs. It supports evaluation of regions of interest and the visual inspection of time density curves. When used by a trained and qualified physician a potential application is to differentiate blood flow between normal and diseased tissue. Determination of the change of perfusion parameters during the course of treatment may be helpful in therapy monitoring.

Vitrea® CT Liver Analysis is a noninyasive post-processing application designed to evaluate liver tumors and plan for liver surgery. It displays images for analysis and preoperative liver surgery planning, such as organ segmentation, tumor segmentation and intrahepatic vessels seqmentation, as well as the approximation of vascular territories. It supports preoperative evaluation of specific surgery strategies by allowing the user to interactively define virtual resections splitting the liver. It also allows the user to evaluate safety-margins around lesions and to identify affected vascular branches and territories. Vitrea® CT Liver Analysis also provides automatic registration of multiple series and measurement tools for characterization and follow-up of the lesions. When used by a trained and qualified physician a potential application is to assist in the assessment of tumor response to therapy.

Vitrea CT Brain Perfusion is a noninvasive post-processing application designed to evaluate areas of brain perfusion. The software can calculate cerebral blood flow (CBF), cerebral blood volume (CBV), local bolus timing (i.e., delay of tissue response, time to peak), and mean transit time (MTT) from dynamic CT image data acquired after the injection of contrast media. The package also allows the calculation of regions of interest and mirrored reqions, as well as the visual inspection of time density curves. Vitrea® CT Brain Perfusion supports the physician in visualizing the apparent blood perfusion in brain tissue affected by acute stroke. Areas of decreased perfusion, as is observed in acute cerebral infarcts, appear as areas of changed signal intensity (lower for both CBF and CBV and higher for time to peak and MTT).

Device Description

VitreaAdvanced is a package of noninvasive post-processing software applications for the Vitrea software platform. The system is a software only medical device to be installed on common IT hardware. VitreaAdvanced leverages existing Vitrea® functionality for the processing, review, analysis, communication, and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. It provides multi-dimensional visualization of digital images to aid medical professionals in their analysis of analomy and pathology. VitreaAdvanced can be used with a variety of cleared Vitrea based software applications. VitreaAdvanced uses the Vitreas system user interface to follow typical clinical workflow patterns and process, review, and analyze digital images, including:

Receive DICOM image data from a variety of sources .
Display images using dedicated protocols adapted to exam types .
Select images for closer examination from collection of 2D. 3D or 4D views .
Interactively manipulate an image in real-time to visualize anatomy and pathology ●
Annotate, tag, measure, and record selected views .
. Output selected views to compatible devices and publishing tools (e.g. printers, DICOM devices, etc.)

In addition, VitreaAdvanced includes three Vitrea® applications:

Vitrea CT Body Perfusion is noninvasive post-processing software that has been designed to assess dynamic (time lapsed collections) CT volume scans and provide data related to the volume sets. It displays blood flow parametric maps for single-input and dual-input workflows.

Vitrea® CT Liver Analysis is noninvasive post-processing software that displays CT image data. It processes image data to segment liver structures and evaluate resection surfaces as well as volumes. Vitreas CT Liver Analysis provides automatic registration and composite views of mulliple series, optimized screen layouts and measurement tools. It also generates standardized reports for WHO and RECIST protocols and for percentage change tumor response values.

Vitrea®CT Brain Perfusion is noninvasive post-processing software that calculates cerebral blood flow (CBF), cerebral blood volume (CBV), local bolus timing (i.e., delay of tissue response, time to peak), and mean transit time (MTT) from dynamic CT image data. It displays time density curves, perfusion characteristics in parametric and summary maps, as well as regions of interest and mirrored regions.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for KIBI213 (VitreaAdvanced), based on the provided text:

Acceptance Criteria and Device Performance for VitreaAdvanced

The submission does not explicitly define specific numerical "acceptance criteria" in the format of a typical performance study with thresholds for metrics like sensitivity, specificity, or accuracy. Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices through a combination of verification, validation, and qualitative assessments.

The "device performance" is primarily reported as confirming that the software's functionality, usability, and performance are similar to or meet the user's needs, as assessed during external validation.

Table of Acceptance Criteria (Inferred) and Reported Device Performance

Given the nature of the submission (510(k) for a post-processing software package without specific de novo clinical claims), the acceptance criteria are more functional and qualitative than quantitative.

Acceptance Criteria (Inferred from Validation Activities)	Reported Device Performance (Summary)
Vitrea® CT Body Perfusion
Deformable (non-rigid) registration produces similar results to scanner console.	Confirmed by external cardiologist.
Registration time is equal to or less than scanner console.	Confirmed by external cardiologist.
Measurements are clinically acceptable.	Confirmed by external cardiologist.
Qualitative analysis (visual verification) of registration is visually similar to scanner-applied registration.	Supported by qualitative analysis.
Vitrea® CT Liver Analysis
Functionality, usability, and performance are acceptable.	Evaluated by two external 3D Technicians, passed external validation.
Vitrea® CT Brain Perfusion
Summary map feature functionality and performance correlation with associated perfusion maps is acceptable.	Evaluated by external radiologist.
Software meets intended use and effectively provides summary image and supports characterization/communication.	Confirmed by external radiologist.
General VitreaAdvanced
Conformance to new and previously defined specifications.	Ensured via manual, automated, and regression tests.
Risks are properly mitigated.	Addressed through risk analysis and testing.
Compliance with DICOM standard.	Designed to meet NEMA PS 3.1 - 3.18 Digital Imaging and Communications in Medicine (DICOM) standard.
Spatial accuracy of image rendering, distance, angular measurement, and navigational tools.	Verified using imaging phantoms.
Accuracy of orientation markers.	Verified using imaging phantoms.

Study Details

Sample size used for the test set and the data provenance:
- Test Set Size: The document does not specify a numerical sample size for "test sets" in the context of a traditional performance study. The validation involved qualitative assessments by experts using "previously acquired medical images" and "various imaging phantoms."
- Data Provenance: The data provenance is not explicitly stated (e.g., country of origin). It refers to "previously acquired medical images" and "imaging phantoms," suggesting retrospective use for verification testing and validation demonstrations.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Vitrea® CT Body Perfusion: An "external cardiologist" was used. Specific years of experience are not mentioned.
- Vitrea® CT Liver Analysis: "Two external 3D Technicians" were used. Specific qualifications (e.g., years of experience) are not mentioned.
- Vitrea® CT Brain Perfusion: An "external radiologist" was used. Specific years of experience are not mentioned.
- General: "Several Radiologists and 3D Technologists" provided feedback and formal acceptance during software testing, but these were for initial validation rather than formal ground truth establishment for a specific test set.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- No formal adjudication method (like 2+1 or 3+1) is described for establishing a "ground truth" in the context of comparative performance. The external validation appears to rely on individual expert confirmation of clinical acceptability and similarity to existing methods.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC study was done. This 510(k) submission describes verification and validation activities for a post-processing software package, not a comparative clinical effectiveness study designed to measure human reader improvement with or without AI assistance. The focus is on demonstrating substantial equivalence to predicate devices and meeting user needs through functional and qualitative assessments.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The submission describes "Automated integration level Build Verification Tests (BVT)," "Automated software rendering tests," "Automated algorithm smoke tests and automated algorithm regression tests," and "Automated performance tests." These can be considered forms of standalone algorithm testing for functional correctness, stability, and performance. However, these are technical tests, not clinical performance tests in a standalone diagnostic capacity. The device is a "post-processing software application" intended for use by a "trained and qualified physician."
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for verification testing of measurements and orientation involved imaging phantoms with known spatial properties.
- For the external validation of the applications, the "ground truth" was effectively expert qualitative assessment and clinical judgment by the cardiologist, 3D technicians, and radiologist, who confirmed clinical acceptability, similarity to existing methods, and fulfillment of intended use. There's no mention of pathology or outcomes data being used for ground truth.
The sample size for the training set:
- The document does not specify a sample size for a training set. The described development and testing process is typical for software validation rather than a deep learning model that requires explicit training data. The software utilizes "previously acquired medical images" for testing, but these are for verification and validation, not specifically for training a machine learning model in the sense of a dataset for supervised learning.
How the ground truth for the training set was established:
- As no training set is explicitly mentioned or described for a machine learning model, the method for establishing its ground truth is not applicable/not provided in this document.

Summary

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KIBI213

510(k) Summary

This 510(k) summary is submitted in accordance with the requirements by section 807.92.(c)

Submitter:	Vital Images, Inc.5850 Opus ParkwaySuite 300Minnetonka, MN 55343-4414
EstablishmentRegistration:	2134213	NOV	2 2012
Contact Person:	Ian NemerovVice President, General Counsel & SecretaryPhone: 952-487-9622Fax: 952-487-9510E-mail: inemerov@vitalimages.com
510(k) Type:	Traditional 510(k)
Summary Date:	October 5,2012
Device Name
Trade Name:	VitreaAdvanced
Common Name:	Picture Archiving and Communications System
Classification Name:	System, Image Processing, Radiological (21 C.F.R. 892.2050,LLZ)

Predicate Devices:

Subject Functions	Predicate Devices
	Manufacturer	Trade Name	510(k) Number
Advanced Image Post-processing	Vital Images, Inc.,	Vitrea®, Version 4.0	K071331
Vitrea® CT Body Perfusion	Toshiba America Medical System, Inc.,	CSBP-001A Body Perfusion System	K090504
Vitrea® CT Liver Analysis	MeVis - Center for Medical Diagnostic Systems and Visualization GmbH	MeVis LiverAnalyser / LiverViewer Software	K051528
	MEDIAN Technologies	LMS-Liver	K071241
	Vital Images, Inc	Vitrea® 4DCT	K072821
Vitrea® CT Brain Perfusion	Siemens Medical Solutions, Inc.	syngo® Volume Perfusion-CT Neuro	K073238

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Device Description:

Receive DICOM image data from a variety of sources .
Display images using dedicated protocols adapted to exam types .
Select images for closer examination from collection of 2D. 3D or 4D views .
Interactively manipulate an image in real-time to visualize anatomy and pathology ●
Annotate, tag, measure, and record selected views .
. Output selected views to compatible devices and publishing tools (e.g. printers, DICOM devices, etc.)

In addition, VitreaAdvanced includes three Vitrea® applications:

Intended Use / Indications for Use:

VitreaAdvanced is a medical diagnostic system for the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. VitreaAdvanced is not meant for primary image interpretation in mammography. It can be used with a variety of cleared Vitreao based software applications. In addition, VitreaAdvanced includes three Vitrea® applications:

Vitrea CT Body Perfusion is a noninvasive post-processing application designed to evaluate perfusion of organs and tumors. The software can calculate perfusion characteristics from dynamic CT image data acquired after the injection of contrast media. The software also allows the separate calculation of the arterial and venous components of perfusion in organs. It supports evaluation of regions of interest and the visual inspection of time density curves. When used by a trained and qualified physician a potential application is to differentiate blood flow between normal and diseased tissue. Determination of the change of perfusion parameters during the course of treatment may be helpful in therapy monitoring.

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Vitrea CT Liver Analysis is a noninvasive post-processing application designed to evaluate liver tumors and plan for liver surgery. It displays images for analysis and preoperative liver surgery planning, such as organ segmentation, tumor segmentation and intrahepatic vessels segmentation, as well as the approximation of vascular territories. It supports preoperative evaluation of specific surgery strategies by allowing the user to interactively define virtual resections splitting the liver. It also allows the user to evaluate safety-margins around lesions and to identify affected vascular branches and territories. Vitrea® CT Liver Analysis also provides automatic registration of multiple series and measurement tools for characterization and follow-up of the fesions. When used by a trained and qualified physician a potential application is to assist in the assessment of tumor response to therapy.

Vitrea CT Brain Perfusion is a noninvasive post-processing application designed to evaluate areas of brain perfusion. The software can calculate cerebral blood flow (CBF), cerebral blood volume (CBV), local bolus timing (i.e., delay of tissue response, time to peak), and mean transit time (MTT) from dynamic CT image data acquired after the injection of contrast media. The package also allows the calculation of regions of interest and mirrored regions, as well as the visual inspection of time densily curves. Vitrea® CT Brain Perfusion supports the physician in visualizing the apparent blood perfusion in brain tissue affected by acute stroke. Areas of decreased perfusion, as is observed in acute cerebral infarcts, appear as areas of changed signal intensity (lower for both CBF and CBV and higher for time to peak and MTT).

Comparison with Predicate Devices:

VitreaAdvanced is a package of noninvasive post-processing software applications for the Vitrea software platform. It leverages the basic functionality and technology of the existing 510(k) cleared Vitrea software platform. VitreaAdvanced includes advance applications that extend the functionality of the platform for specific uses. The specific uses are substantially equivalent to the cleared uses of existing post-processing software applications available on other platforms. Also, the software applications use similar technology as existing post-processing software applications.

Vitrea® CTBodyPerfusion(SubmissionSubject).	Description	Toshiba CSBP-001ABody PerfusionSystem (K090504)	Explanation of Differences
Analysis Model	Maximum slope (Fickprincipal)	Includes	The subject and predicateboth implement Maximum-slope.The predicate implementsadditional models:Compartment model andPatlak Plot.

Vitrea® CT Body Perfusion:

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Vitrea® CTBodyPerfusion(SubmissionSubject)	Description	Toshiba CSBP-001ABody PerfusionSystem (K090504)	Explanation of Differences
Parameters	Blood flow	Includes	The subject and predicateboth display blood flowparameters.The predicate includesadditional parameters: Bloodvolume, MTT, HAF (PI),equivalent blood volumeusing the additional analysismodels.
Functions	Single input, dualinput, map display andROI measurement	Same	None

Vitrea® CT Liver Analysis:

Vitrea® CTLiver Analysis(SubmissionSubject)	Description	MeVis LiverAnalyser /LiverViewerSoftware(K051528)	Median LMS-Liver(K071241)	Explanation ofDifferences.
Analysis Model	Rigid and deformableregistration,Segmentation andregion growing	Same	Same	None
Parameters	Basic measurements,volume, resectionplane, RECIST, WHOand comparisons	Partial(volumes,resectionplanes andcomparisons)	Partial(RECIST,WHO andcomparisons)	MeVis providesbasicmeasurementsfor volumes,resection planesand comparisons.LMS-Liverprovides RECISTand WHOmeasurementsand comparison.

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Vitrea® CTLiver Analysis(SubmissionSubject)	Description	MeVis Liver -Analyser /LiverViewerSoftware(K051528)	Median LMS-Liver .(K071241) :	Explanation ofDifferences
Functions	Segment: organs,tumors andintrahepatic vessels.Resection planningtool (defines vascularterritories), multi-phasefusion andstandardized reports	Partial(segmentation,resectionplanning andmulti-phasefusion)	Partial(standardizedreports)	MeVis providessegmentation,resectionplanning andmulti-phasefusion.LMS-Liverprovidesstandardizedreports.

Vitrea® CT Liver Analysis:

Vitrea® CTBrainPerfusion(SubmissionSubject)	Description	Vitrea® 4DCT(K072821)	Siemens syngo®VolumePerfusion –CT Neuro(K073238)	Explanation ofDifferences
Analysis Model	Deconvolution	Same	Includes	syngo® VolumePerfusion-CTNeuro uses bothdeconvolutionand maximumslope.
Parameters	Cerebral blood flow(CBF), cerebral bloodvolume (CBV), localbolus timing (i.e., delayof tissue response,time to peak), andmean transit time (MTT)	Same	Includes	syngo® VolumePerfusion-CTNeuro hasall theparameters andvascularpermeability

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Vitrea® CTBrainPerfusion(SubmissionSubject)	Description	Vitrea® 4DCT.(K072821)	Siemens syngo®VolumePerfusion -CT Neuro(K073238)	Explanation of'Differences'
Functions	Display regions ofinterest, mirroredregions, time densitycurves and perfusioncharacteristics inparametric andsummary maps	Partial	Same	4DCT does notinclude summarymaps (maps thatcombineparameters).syngo®VolumePerfusion- CTNeuro includesmaps thatcombineparameters.

Summary of Non-Clinical Tests:

VitreaAdvanced was designed, developed, and tested according to written procedures that included applying risk management. Testing included verification, and evaluation of previously acquired medical images.

The following quality assurance measures were applied to the development of VitreaAdvanced:

Risk analysis .
. Requirements reviews
. Design reviews
Performance testing (Verification) .
Safety testing (Verification) .
Simulated use testing (Validation) .

Software Testing:

The primary focus of the Verification and Validation team during development was producing, reviewing and execuling manual and automated test cases to ensure the product conformed to new and previously defined specifications and also to ensure that risks were properly mitigated during testing. The Requirement Traceability Matrix (RTM) provides a mapping between requirements, risks, test cases, and shows related test results. The RTM confirms that there was a test case authored and executed for all requirements and any applicable risks. In addition, the Verification and Validation Team demonstrated clinical features to several Radiologists and 3D Technologists to gather feedback and formal acceptance.

Manual Tests:

Manual tests cases were executed to verify and validate the CT Body Perfusion, CT Liver Analysis and CT Brain Perfusion applications, and to determine the impact of any changes. All manual tests and steps were executed to prove the product conformed to specifications and to mitigate risks.

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Verification:

The software verification team had a primary goal of assuring that software fully satisfies all expected system requirements and features. Test cases were executed against the system features and requirements. As part of creating the test cases, the verification team reviewed and monitored the Requirements Traceability Matrix ("RTM") to ensure coverage of the items within the RTM.

Automated Integration Level Build Verification Tests (BVT):

Automated integration level Build Verification Tests (BVT) were developed to exercise mainstream functionality and provide an assessment of the stability of the VitreaAdvanced software. Automated software rendering tests were used to verify correctness of images generated by the rendering engine. Automated algorithm smoke tests and automated algorithm regression tests were executed. Automated performance tests were used to verify that response times and throughput were acceptable. Automated regressions tests were used to verify correctness of measurements, orientation markers, and other core features of VitreaAdvanced.

Validation:

The software validation team had a primary goal of assuring that software conforms to user needs and intended uses. The result of the validation team's efforts was evidence, produced by workflow testing, that system requirements and features were implemented, reviewed and met.

Internal Validation:

The software validation team provided internal validation of VitreaAdvanced. Internal validation included internal beta testing and internal user acceptance testing.

External Validation:

Vitrea® CT Body Perfusion

During external validation of CT Body Perfusion of VitreaAdvanced, an external cardiologist confirmed that the CT Body Perfusion application's deformable (non-rigid) registration for dynamically scanned organs produces similar results to what is available on the scanner console. It was also confirmed that it takes the same amount of time or less to complete registration.

The results of the qualitative analysis (visual verification), performed as part of validation, support the feedback received from the cardiologist during external validation regarding the visual similarity of images produced by the VitreaAdvanced registration to the registration applied at the scanner. In addition, a cardiologist also confirmed the measurements produced were clinically acceptable and that the software was ready for general release. Based on the results of the qualitative analysis, and feedback gathered during external validation, the CT Body Perfusion application has passed validation.

Vitrea® CT Liver Analysis

During external validation of CT Liver Analysis application of VitreaAdvanced, two external 3D Technicians evaluated the functionality, usability and performance of the CT Liver Analysis application. Based on their evaluation, the software passed external validation.

Vitrea® CT Brain Perfusion

During external validation of CT Brain Perfusion of VitreaAdvanced, an external radiologist evaluated the functionality and performance of the summary map feature and the correlation of each summary map with his interpretation of that summary map's associated perfusion maps. He confirmed that the software has met the intended use and effectively provides a summary image of the data displayed in the perfusion maps as well as when used in conjunction with the perfusion maps, the summary map enables the user to characterize the brain tissue and communicate their findings.

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Summary of Clinical Tests:

The subject of this traditional 510(k) notification, VitreaAdvanced, did not require clinical studies to support safety and effectiveness of the software.

Cyber and Information Security:

. Confidentiality

Vitrea platform relies on built in Windows Login security to limit access to the system. The Vitrea platform can only be installed and configured by an administrator of the Windows machine.

. Integrity
Vitrea platform complies with the DICOM standard for transfer and storage of this data and does not modify the contents of DICOM instances. Vitrea platform identifies the data it produces, marking and encoding the appropriate DICOM fields.

. Availability

Vitrea platform is always available to the logged on user as long as the Windows machine itself is properly maintained.

. Accountability

Vitrea platform includes an audit capability that enables accountability by tracking authenticated and authorized user operations along with information accessed. Vitrea audit logs are time stamped, enabling correlation with Windows system logging to track information accessed by a user.

Measurement Accuracy:

Measurements and orientations in VitreaAdvanced were verified using various imaging phantoms. These imaging phantoms contain markers at known positions, distances, and angles from one another. The known positions, distances, and angles were used as input into expected results for verification tests that verified the spatial accuracy of image rendering of 2D and 3D images, the accuracy of distance, angular measurement, and navigational tools, as well as the accuracy of orientation markers within VitreaAdvanced.

Performance Standard:

No applicable mandatory performance standards or special controls exist for this device. However, the software is designed to meet NEMA PS 3.1 - 3.18 Digital Imaging and Communications in Medicine (DICOM) standard.

Conclusion:

The testing reported in this 510(k) establishes that VitreaAdvanced is substantial equivalent to the predicate devices and is safe and effective for its intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Mr. Daniel Biank Regulatory Affairs Manager Vital Images, Inc. 5850 Opus Parkway, Suite 300 Minnetonka, MN 55343

Re: K121213

Trade/Device Name: VitreaAdvanced Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 5, 2012 Received: October 9, 2012

Dear Mr. Biank:

We have reviewed vour 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

2 2012 NOV

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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,

Janine M. Morris

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): K121213

Device Name: VitreaAdvanced

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

Michael D'Auria, CR

Invision of Radiotogical Hea

510(k) K121213

Regulation Number and Section

§ 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).