(63 days)
Visage PACS/CS: is a system for distributing, viewing, and processing medical images and reports within and outside health care environments. It is to be used only by trained and instructed health care professionals. Visage PACS consists of the following components:
Visage PACS Storage: Visage PACS Storage offers an archiving option for long-term storage of image data
Visage PACS Web: Data that are stored on the Visage PACS Storage server can be accessed simultaneously by multiple web-based viewing stations within or outside a healthcare enterprise through web clients.
Visage CS: Visage CS is a client server system that uses thin client technology for distribution of 3D image data generated from image data of state-of-the-art scanning modalities
Integration with other hospital information systems (HIS, RIS, CIS) is provided via special interfaces.
Visage PACS is a system to distribute, view, and process medical images and reports within and outside of health care environments. It consists of the following components:
- Visage PACS Storage -
- Visage PACS Web -
- Visage CS -
Visage PACS Storage: A server receives image data in DICOM format via the hospital network. This provides universal connections to archives, modalities and workstations. Visage PACS Storage offers an archiving option for long-term storage of image data.
Visage PACS Web: Data that are stored on the Visage PACS Storage server can be accessed simultaneously by multiple web-based viewing stations within a healthcare enterprise or from elsewhere outside through web clients. The image data transfer is done in DICOM format via the Intranet or the Internet. Images can be viewed directly within a web browser (Internet Explorer). The system offers simple functions for image manipulation and measurements. Reports can be viewed together with the images on one page.
Visage CS: Visage CS is a client server system that uses thin client technology for distribution of 3D image data generated from image data of state-of-the-art scanning modalities. The thin client viewer allows to view and process 3D image data. No DICOM data is transferred to the client. Instead of image data, a stream of compressed screen content information is transmitted during interaction.
The provided document (K062496, VISAGE PACS/CS Premarket Submission Summary dated August 24, 2006) describes a Picture Archiving and Communications System (PACS) and does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of clinical performance or diagnostic accuracy.
Instead, the submission focuses on:
- Substantial Equivalence: It asserts that the VISAGE PACS/CS is substantially equivalent to a predicate device (TeraRecon AquariusNet Server/Thin client, K012086). The "Substantial Equivalence Comparison Chart" (pages 5-6) details similarities in functionality, hardware/software requirements, and features between the Visage PACS/CS, the predicate device, and a previous version of the submitter's product (RADIN 3.0). This comparison serves as the primary and only "study" presented to demonstrate equivalency and fitness for purpose.
- Software Development Process and Risk Analysis: It states that the software was "designed, developed, tested and validated according to written procedures" and that a "risk analysis has been performed to identify all potential safety or health hazards."
Therefore, it is not possible to fill out the requested table and details because the submission does not include elements such as:
- Specific Acceptance Criteria related to diagnostic performance (e.g., sensitivity, specificity, AUC).
- Device Performance Metrics against such criteria.
- Details of a test set (sample size, data provenance), ground truth establishment (number/qualifications of experts, adjudication methods, type of ground truth), or training set details.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance studies.
The document aims to establish substantial equivalence primarily through a feature-by-feature comparison with a legally marketed predicate device, rather than through a direct clinical performance study with defined acceptance criteria and statistical analysis.
No study proving the device meets acceptance criteria regarding diagnostic performance or clinical effectiveness is described in this document. The safety and effectiveness claims are based on the device's substantial equivalence to a predicate device and adherence to quality system regulations and a risk management plan.
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K06 2496
Premarket Submission VISAGE PACS/CS Summary
24 Aug 2006
A.1 510(k) Summary of Safety and Effectiveness
A.1.1 Company Identification
Mercury Computer Systems, Inc. 199 Riverneck Road Chelmsford, MA 01824-2820 United States of America
A.1.2 Official Correspondent
Richard Glasheen 199 Riverneck Road Chelmsford, MA 01824-2820 United States of America Tel.: 978-967-1843 Fax: 978-256-0588 E-Mail: rglashee@mc.com
A.1.3 Date of Submission
24 Aug 2006
A.1.4 Device Name
| Trade name: | VISAGE PACS/CS |
|---|---|
| Release Version: | 4.1 |
| Common name: | VISAGE PACS/CS |
| Classification Name: | Picture Archiving and Communications System |
| Reference: | per 21 CFR 892.2050 |
| Class: | II |
| Review Panel: | Radiology |
| Product Classification: | 90 LLZ, Picture Archiving and Communications System |
Guidance for the submission of premarket notifications for Guidance document: medical image management systems (issued on july 27, 2000)
A.1.5 Substantial Equivalence
The Visage PACS/CS Software is substantially equivalent, in the opinion of Mercury Computer Systems Inc., to TeraRecon AquariusNet Server/Thin client (K012086, Class II).
A.1.6 Device Description
Visage PACS is a system to distribute, view, and process medical images and reports within and outside of health care environments. It consists of the following components:
- Visage PACS Storage -
- Visage PACS Web -
- Visage CS -
Visage PACS Storage
OCT 2 7 2006
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A server receives image data in DICOM format via the hospital network. This provides universal connections to archives, modalities and workstations. The modalities that are supported by Visage PACS Storage are listed in the DICOM Conformance Statement.
Visage PACS Storage offers an archiving option for long-term storage of image data. Only the data consistency on archive media is guaranteed, the system provider has to take own appropriate means (e.g. redundancy) for safety against data loss caused by media destruction. Without the archiving option, the Visage PACS system features no components for long-term data archiving. Additional archiving on film or in digital form is therefore necessary.
Visage PACS Web
Data that are stored on the Visage PACS Storage server can be accessed simultaneously by multiple web-based viewing stations within a healthcare enterprise or from elsewhere outside through web clients.
The image data transfer is done in DICOM format via the Intranet or the Internet, for example to stations located in a doctor's office, throughout hospitals or a physician's home. Strong data encryption is provided (SSL) to ensure a secure data transfer. Images can be viewed directly within a web browser (Internet Explorer). The system offers simple functions for image manipulation and measurements.
Reports can be viewed together with the images on one page.
Visage CS
Visage CS is a client server system that uses thin client technology for distribution of 3D image data generated from image data of state-of-the-art scanning modalities. The thin client viewer allows to view and process 3D image data. No DICOM data is transferred to the client. It remains on the 3D Application Server at any time, ensuring safe and consistent access to large 3D data throughout the hospital enerprise. Instead of image data, a stream of compressed screen content information is transmitted during interaction. If Visage CS is used in un-secure networks (e.g. WAN) third party VPN (Virtual Private Network) solutions have to be used to secure the data transfer between the Visage Server and the client machines.
A.1.7 Intended Use
Visage PACS is a system for distributing, viewing, and processing medical images and reports within and outside health care environments. It is to be used only by trained and instructed health care professionals. Visage PACS consists of the following components:
-
Visage PACS Storage
-
। Visage PACS Web -
- Visage CS
Integration with other hospital information systems (HIS, RIS, CIS) is provided via special interfaces.
Visage PACS Storage
A server receives image data in DICOM format via the hospital network. This provides universal connections to archives, modalities, and workstations. The modalities that are supported by Visage PACS Storage are listed in the DICOM Conformance Statement.
Visage PACS Storage offers an archiving option for long-term storage of image data. The system guarantees the consistency of the data stored on archiving media but does not prevent data loss caused by media destruction.
Visage PACS Web
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Data that are stored on the Visage PACS Storage server can be accessed simultaneously by multiple web-based viewing stations within or outside a healthcare enterprise through web clients.
The image data are transferred in DICOM format via the Intranet or the Internet, for example to stations located in a doctor's office, throughout hospitals or a physician's home. Strong data encryption is provided (SSL) to ensure secure data transfer. Images can be viewed directly within a web browser (Internet Explorer). The system offers simple functions for image manipulation and measurements. Reports can be viewed together with the images on one page.
Visage CS
Visage CS is a client server system that uses thin client technology for distribution of 3D image data generated from image data of state-of-the-art scanning modalities.
The thin client viewer allows viewing and processing of 3D image data. No DICOM data is transferred to the client. It remains on the 3D Application Server at all times, ensuring safe and consistent access to large volumes of 3D data throughout the hospital enterprise. Instead of image data, a stream of compressed screen content information is transmitted during interaction.
If Visage CS is used in insecure networks (e.g. WAN), third party VPN (Virtual Private Network) solutions have to be used to secure data transfer between the Visage Server and the client machines.
Important Usage Notes
Visage PACS can support physicians and/or their medical staff in providing their own diagnosis for medical cases. The final decision regarding diagnoses, however, resides with the doctors and/or their medical staff in their own area of responsibility.
Although the web and thin client technologies allow the software to be run on a variety of hardware platforms, for diagnostic purposes the user must make sure that the display hardware used for reading the images complies with state-of-the-art diagnostic requirements and currently valid laws.
Mammographic images compressed by a lossy method and digitized film screen images must not be reviewed for primary image interpretations.
The computers hosting the server-side software of Visage PACS/CS must be operated in a server room ensuring the appropriate operating and environmental conditions and access control.
A.1.8 Software Development
Mercury Computer Systems, Inc. certifies that the VISAGE PACS/CS software is designed, developed, tested and validated according to written procedures. These procedures identify individuals within the organization responsible for developing and approving product specifications, coding and testing, validation testing and field maintenance. All employees receive the appropriate quality system training.
The Mercury Computer Systems, Inc. Quality System is in compliance with the following voluntary and mandatory standards and regulations:
| Standard/Regulation | Title |
|---|---|
| 21 CFR 820 | Quality Systems Regulation |
| ISO 9001:2000 | Quality Management Systems - Requirements |
| ISO 13485:2003 | Quality Systems - Medical Devices - Particular requirementsfor the application of ISO 9001 |
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| 93/42/EEC | Medical Device Directive | |
|---|---|---|
| and and the beginner for the first for the first of the first and the first and the first and the first and the first and the first and the first and the first and the first(IEC) 60601-1-4------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | International Electrotechnical Commission |
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A.1.9 Substantial Equivalence Comparison Chart
Annotation:
Our Visage product line consists of 2D Web based PACS software and a separate 3D Visage Server and Thin Clients to give the end user a complete 2D/3D PACS experience. The software backend of the Visage product is based on the RADIN 3.0 product that received 510(k) approval (K043483) from the FDA In 2004. RADIN 3.1 was granted 510(k) approval to Sohard AG which was acquired by Mercury Computer Systems, Inc. in 2005.
TeraRecon unites 2D/3D into one System, AquariusNet Server and Thin Clients, but has no PACS functionality. TeraRecon also provides the same Thin Client software suite on a stand- alone workstation, Aquarius Blue.
Image /page/4/Figure/7 description: This image shows a diagram of a medical imaging system. The diagram includes components such as an Aquarius Workstation, AquariusNET, Personal Digital Light Box, and Thin Client. The diagram also shows connections between the different components, indicating how they are integrated within the system. The text in the image includes labels for the different components, as well as the phrases "Powered by VolumePro" and "Powered by TeraRecon F-1".
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| Substantial Equivalence comparison Chart | |||
|---|---|---|---|
| -- | -- | ------------------------------------------ | -- |
| Product | Visage PACS/CS4.1 | AquariusNetServer/Thin client | RADIN 3.0 |
|---|---|---|---|
| Company Name | Mercury ComputerSystems, Inc. | TeraRecon, Inc. | Mercury ComputerSystems, Inc.Formally SoHardAG |
| 510 (k) number | TBD | K012086 | K043483 |
| General | |||
| Networking | TCP/IP | Yes | TCP/IP |
| Image Acquisition/Communication | DICOM Compliant | Yes | DICOM Compliant |
| Image file formats | DICOM 3.0 | Yes | DICOM 3.0 |
| Imaging modalities | Multi Modality | Yes | Multi Modality |
| Platform | PC | PC | PC |
| Operating System | Windows | Windows | Windows |
| Standard Microsoft Technology | Yes | Yes | Yes |
| DICOM 3.0 Compliant | Yes | Yes | Yes |
| Patient Demographics | Yes | Yes | Yes |
| DICOM Storage SCP | Yes | Yes | Yes |
| DICOM Storage SCU | Yes | Yes | Yes |
| DICOM Query/Retrieve SCU/SCP | Yes | Yes | Yes |
| DICOM Storage Commitment | Yes | Yes | No |
| HIPAA compliant | Yes | Yes | Yes |
| Secure data transmission | SSL encryption,VPN encryption | VPN, encryption | Yes |
| User authentication | Yes | Yes | Yes |
| User Account | Yes | Yes | Yes |
| User groups | Yes | Yes | Yes |
| User Levels | Yes | No | Yes |
| Visage PACS/CS Online | |||
| Scalability | |||
| Concurrent user model | Yes | Yes | Yes |
| Data Storage | |||
| Format | |||
| Original Format | Yes | Yes | Yes |
| JPEG Lossless | Yes | Yes | Yes |
| JPEG Lossy | Yes (5-100%) | Yes | Yes (5-100%) |
| Wavelet | Yes (5-100%) | Yes (0-100%) | Yes (5-100%) |
| Storage SpaceManagement | |||
| Intelligent storagemanagement | Yes | Yes | Yes |
| Data Storage | |||
| Device | |||
| RAID, SAN, NAS | 250GB to severalTB | RAID, SAN, NAS | |
| DICOM Network | |||
| DICOM Confor-mance | DICOM 3.0 | DICOM 3.0 | DICOM 3.0 |
| Hardware and Soft-ware Requirementsfor server | |||
| HardwareSoftware | PC 2x Pentium III1,4 GHz or PC 1xPentium IV 3GHz(Hyperthreading),>= 1GB RAM2x 60 GB HarddiskSCSI or SATAWindows2003 | WorkstationLatestDell Power SolutionVolumePro(Ter-Graphicsrarecon)Board,Pentium4Intelprocessor, 2.0 GHzor faster512MB of SDRAMsystem memory120GB HardDiskDrive storageWindowsNT4.0. | PC111,Pentiummin 500MHz512 MB RAM20 GB HarddiskWindows2003 |
| ServerInternet Explorer 6 | Windows 2000, Win2003 | ServerInternet Explorer 6 | |
| Workflow Features | |||
| DICOM report inter-face | Yes | Yes | Yes |
| File based reportinterface | Yes | Yes | Yes |
| URL interface forOEM integration | Yes | Yes | Yes |
| Creation of patientmedia (DVD) ac-cording to DICOMstandard | Yes | Yes | Yes |
| Visage PACS/CS3D Server | |||
| Scalability | Yes | Yes | Yes |
| Data Storage For-mat | |||
| Volume Data | Yes | Yes | |
| Hardware and Soft-ware Requirements | |||
| Hardware | Minimum 2x dualcore Opteron, 8GBRAM, graphicadapter 2xFX4500, 1x 160GBHarddisk | Workstation LatestDell Power SolutionVolumePro (Terare-con) GraphicsBoard,Pentium 4 Intelprocessor, 2.0 GHzor faster512MB of SDRAMsystem memory120GB Hard DiskDrive storage | Pentium 2 GHz512 MB RAM50-100 GB Hard-disk |
| Software | SuSe Linux version10.0 | Windows NT 4.0,Windows 2000, Win2003 | Windows 2003ServerInternet Explorer 6 |
| Workflow Features | |||
| URL interface forOEM integration | Yes | Yes, added capabil-ity | Yes |
| Visage PACS/CSArchive | |||
| Storage Modules | |||
| Harddisk RAID | Yes | Yes | |
| SAN systems | Yes | Yes | |
| NAS systems | Yes | Yes | |
| Data Security | |||
| Data verification onmedia | Yes | No | Yes |
| Manipulation detec-tion | Yes | No | Yes |
| Database consis-tency check | Yes | No | Yes |
| Archive type | PACS | PACS or UNCmount point storage | PACS |
| Hardware and Soft-ware Requirements | |||
| Hardware | Pentium 2 GHz512 MB RAM50-100 GB Hard-disk | Standard Dell HighPerformance Prod-uct | |
| Software | Windows 2003ServerInternet Explorer 6 | Windows NT 4.0,Windows 2000 | |
| Visage PACS/CSWEB Client | |||
| Key Features | |||
| Full DICOM imageson clients | Yes | Yes | No |
| No Software Installa-tion, just InternetExplorer needed | Yes | No, thin client alsofor 2D part. Alsohas activeX clientthat can run withinIE and does notrequire clientdownload. | Yes |
| Supported Modali-ties | CR, CT, DR, DS,DX, ES, GM, IO,MG, MR, NM, PT,OT, RF, RT, US,XA, XC | CR,CT,MR,DR, US,PT, NM, DX, OT,RF, SC, XF, XA | CR, CT, DR, DS,DX, ES, GM, IO,MG, MR, NM, PT,OT, RF, RT, US,XA, XC |
| Supported ImageTypes | |||
| Greyscale, Color,Multiframe | Yes | Yes | Yes |
| Image ManipulationFunctions | |||
| Zoom | Yes | Yes | Yes |
| Quick Zoom | Yes | Yes | Yes |
| Magnifying glass | Yes | No | Yes |
| Pan | Yes | Yes | Yes |
| Window leveling | Yes | Yes | Yes |
| Edge enhancement | Yes | Yes | Yes |
| Grayscale inversion | Yes | Yes | Yes |
| Rotating, flipping | Yes | Yes | Yes |
| MPR, MIP | Yes | Yes | No |
| MeasurementFunctions | |||
| Distance | Yes | Yes | Yes |
| Angulation | Yes | Yes | Yes |
| Area | Yes | Yes | Yes |
| Greyscale densitiy(probe) | Yes | Yes | Yes |
| Manual distancecalibration | Yes | Yes | Yes |
| Cine Mode | Yes | Yes | Yes |
| Workflow features | |||
| Database Filters | Yes | Yes | Yes |
| DICOMquery/retrieve fromarchives and work-stations | Yes | Yes | Yes |
| Change user andgroup assignment ofpatients | Yes | Yes | Yes |
| Multiple series load-ing | Yes | Yes | Yes |
| Preloading of im-ages to the client | Yes | No - Not needed | Yes |
| Study availabilitystatus | Yes | No - if study is inthe worklist it isavailable. Loadtime from PACSarchive for 500 im-age CT dataset is<30 secs | Yes |
| Display of imagestogether with reports | Yes | Yes | Yes |
| Creation and Modifi-cation of advancedreport annotations | Yes | Yes | Yes |
| Easy integration withRIS/HIS systems | Yes | No | Yes |
| Windows Copy andPrint Functions | Yes | Yes | Yes |
| DICOM print | Yes | Yes | Yes |
| Hardware and Soft-ware Requirements | |||
| Hardware | Minimum Pentium III 500 MHz, 256 MB RAM, Standard PC graphics card 1024 * 768 true color, 2 GB Harddisk space, Network or telephone adapter | 300MHz Pentium® MMX, Standard 2D video graphics adapter | Pentium III 500 MHz, (Pentium IV 2 GHz recommended) 128 MB RAM (512 MB recommended) Standard PC graphics card, 1024 * 768 minimum resolution 2 GB Harddisk Network or telephone adapter |
| Software | Microsoft Windows 2000 or XP Internet Explorer 6.0 | Windows 2000, NT, XP, or 98, Win 2003 | Microsoft Windows 2000 or XP Internet Explorer 5.5 or 6.0 |
| Additional Features | |||
| Multiple Monitor Support | Yes | Yes | Yes |
| Support for High Resolution Monitors | Yes | Yes - No upper limit | |
| Key Features | Thin Client Not supported by RADIN | ||
| Supported Modalities | CT, MR, PT | CT, MR, PT, US, CR, DR, XA, NM, FL | CT, MR, PT |
| Supported Image Types | |||
| Greyscale | Yes | Yes | |
| Image Manipulation Functions | |||
| Zoom | Yes | Yes | |
| Pan | Yes | Yes | |
| Window leveling | Yes | Yes | |
| Grayscale inversion | Yes | Yes | |
| 3D Volume Navigation | Yes | Yes | |
| MPR, MIP | Yes | Yes | |
| Measurement Functions | |||
| Distance | |||
| Angulation | Yes | Yes | Yes |
| Area | Yes | Yes | Yes |
| Greyscale density(probe) | Yes | Yes | Yes |
| Annotations | Yes | Yes | Yes |
| Cine Mode | Yes | Yes | Yes |
| Workflow features | |||
| Database Filters | Yes | Yes | |
| DICOMquery/retrieve fromarchives and work-stations | Yes | Yes | |
| Multiple series load-ing | Yes | Yes | |
| Easy integration withRIS/HIS systems | Yes | No | |
| Windows Copy andPrint Functions | Yes | Yes | |
| result image export | Yes | Yes | |
| predefined protocolsand layouts for eachmodality and screensetup | Yes | Yes | |
| User defined colorand 3D renderingschemes | Yes | Yes | |
| Large Vessel Ap-plication | |||
| Freehand croppingand patient tableremoval | Yes | Yes | |
| Curved reformatting | Yes | Yes | |
| Semi-automaticlarge vessel seg-mentation | Yes | Yes | |
| Quick navigationalong vessels | Yes | Yes | |
| Easy measurementof vessel cross sec-tion | Yes | Yes | |
| PET/CT and NMApplication | |||
| Optimized for com-bined PET/CT mo-dalities | Yes | Yes | |
| Predefined PET/CTprotocols and NMcolormaps | Yes | Yes | |
| MPR and VRT fu-sion display, inverseMIP | Yes | Yes | |
| Manual correction ofspatial registration | Yes | Yes | |
| Hardware and Soft-ware Requirements | |||
| Hardware | The thin client runson any x86 com-patible processorsupporting theMMX instructionset (e.g. Intel Pen-tium I MMX, AMDK6, or higher). | 300MHz Pentium®MMX ,Standard 2Dvideo graphicsadapter | |
| Software | Microsoft Windows2000 or XP | Windows 98, NT,2000, XP, Win 2003 | |
| Advanced 3D Visu-alization Features | |||
| 3D and 4D Naviga-tion | Yes | Yes | |
| Orthogonal and per-spective viewingprojection | Yes | Yes | |
| VRT, SVRT | Yes | Yes | |
| Cropping and clip-ping | Yes | Yes | |
| Additional Features | |||
| Mulitple MonitorSupport | Yes | Yes |
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Mercury Computer Systems, Inc.
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Premarket Submission
VISAGE PACS/CS Summary
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Premarket Submission
VISAGE PACS/CS Summary
24 Aug 2006
・
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Premarket Submission
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| Hardware andSoftwareRequirements | Premarket SubmissionVISAGE PACS/CS Summary | Mercury Computer Systems, Inc.199 Riverneck RoadChelmsford, MA 01824-2820United States of America | |
|---|---|---|---|
| Hardware | Pentium 2 GHz512 MB RAM50-100 GB Harddisk | 24 Aug 2006Standard Dell HighPerformance Product | |
| Software | Windows 2003 ServerInternet Explorer 6 | Windows NT 4.0,Windows 2000 | |
| Visage PACS/CSWEB Client | AquariusNetServer/Thin cli-ent | RADIN 3.0 | |
| Key Features | |||
| Full DICOM imageson clients | Yes | Yes | |
| No SoftwareInstallation, justInternet Explorerneeded | Yes | No, thin client also for2D part. Also hasactiveX client that canrun within IE and doesnot require clientdownload. | Yes |
| Supported Modalities | CR, CT, DR, DS, DX,ES, GM, IO, MG, MR,NM, PT, OT, RF, RT,US, XA, XC | CR,CT,MR,DR, US,PT, NM, DX, OT, RF,SC, XF, XA | CR, CT, DR, DS, DX,ES, GM, IO, MG, MR,NM, PT, OT, RF, RT,US, XA, XC |
| Supported ImageTypes | |||
| Greyscale, Color,Multiframe | Yes | Yes | Yes |
| Image ManipulationFunctions | |||
| Zoom | Yes | Yes | Yes |
| Quick Zoom | Yes | Yes | Yes |
| Magnifying glass | Yes | No | Yes |
| Pan | Yes | Yes | Yes |
| Window leveling | Yes | Yes | Yes |
| Edge enhancement | Yes | Yes | Yes |
| Grayscale inversion | Yes | Yes | Yes |
| Rotating, flipping | Yes | Yes | Yes |
| MPR, MIP | Yes | Yes | No |
| MeasurementFunctions | |||
| Distance | Yes | Yes | Yes |
| Angulation | Yes | Yes | Yes |
| Area | Yes | Yes | Yes |
| Greyscale density(probe) | Yes | Yes | Yes |
| Manual distance cali-bration | Yes | Yes | Yes |
| Cine Mode | Yes | Yes | Yes |
| Workflow features | |||
| Database Filters | Yes | Yes | Yes |
:
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A.1.10Safety and Effectiveness
General Safety and Effectiveness Concerns A.1.10.1
VISAGE PACS/CS is a medical device that is to be used by trained health care professionals who are responsible for the correct and accurate use of medical images e.g. as a means for providing diagnosis.
The device labeling contains instructions for use and the intended use/indications for use. Warnings, faults etc are explained in the users manual.
Data that are compressed are properly identified in the image information as being compressed as specified by the DICOM standard. This compression identification remains with the image for the entire life of the image. The correctness of the compression 3d party software is validated by the testing routine for 3d party components during the system/integration test.
A.1.10.2 Validation and Effectiveness
The VISAGE PACS/CS risk analysis has been performed to identify all potential safety or health hazards during system operation. The hazards are controlled by a risk management plan, including hazard analysis, verification and validation tests (according to our software development process) and evaluations by hospitals.
According to our risk analysis and risk management there are no software components within the VISAGE PACS/CS Software, whose failure or latent design flaw would be expected to result in death or injury to a patient.
Requirement tracing covering specification, design, implementation and verification/validation ensures the fulfillment of all phase requirements, EHR and DMR ensures direct access to all documents.
Integration test plan defines full testing at integration and system testing level. According to this test plan integration and system testing including full testing of hazard mitigation has been performed.
Decision Reviews at the conclusion of each software development phase ensure the fulfillment of the phase results and the validity of the Intended Use and the risk analysis. Testing is an integral part of our Software Design Process.
A.1.10.3 Substantial Equivalence
Any differences between the VISAGE PACS/CS Software and the substantially equivalent device have no significant influence on safety and effectiveness.
A.1.10.4 Technological characteristics
VISAGE PACS/CS is a stand-alone software package used on general purpose hardware, as long as the minimum hardware requirements specified in the manuals are met.
It is based upon standard Microsoft™ technology,
The device does not contact the patient, nor does it control any life sustaining devices.
A physician, providing ample opportunity for competent human intervention interprets images and information delivered by VISAGE PACS/CS.
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A.1.10.5 Conclusion
We believe that the 510(k) premarket notification contains adequate information and data to enable FDA to determine substantial equivalence to the predicate device.
VISAGE PACS/CS has been and will be manufactured in accordance with the mandatory and voluntary standards listed in this submission.
This submission contains the result of the hazard analysis and all potential hazards have been classified as minor.
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Image /page/16/Picture/1 description: The image is a circular seal or logo. It features the emblem of the U.S. Department of Health & Human Services (HHS). The emblem consists of a stylized caduceus-like symbol with three lines extending from a central point, resembling a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
OCT 2 7 2006
Mr. Richard Glasheen Official Correspondent Mercury Computer Systems, Inc. 199 Riverneck Road CHELMSFORD MA 01824-2820
Re: K062490
Trade/Device Name: VISAGE PACS/CS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 24, 2006 Received: August 31, 2006
Dear Mr. Glasheen:
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 either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.
Image /page/16/Picture/10 description: The image is a black and white circular logo. The logo contains the text "1906-2006" at the top, "PA" in the center, and "Centennial" at the bottom. There are three stars below the word "Centennial". The logo appears to be a commemorative emblem for a centennial celebration.
Protecting and Promoting Public Health
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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); 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.
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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. B rogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section D: Statement of Indications for Use
Amended Version 1: Indication for Use Amendment Date: 17 Oct 2006
510(k) Number: K062490 Device Name: VISAGE PACS/CS Indications for Use:
Visage PACS/CS: is a system for distributing, viewing, and processing medical images and reports within and outside health care environments. It is to be used only by trained and instructed health care professionals. Visage PACS consists of the following components:
Visage PACS Storage: Visage PACS Storage offers an archiving option for long-term storage of image data
Visage PACS Web: Data that are stored on the Visage PACS Storage server can be accessed simultaneously by multiple web-based viewing stations within or outside a healthcare enterprise through web clients.
Visage CS: Visage CS is a client server system that uses thin client technology for distribution of 3D image data generated from image data of state-of-the-art scanning modalities
Integration with other hospital information systems (HIS, RIS, CIS) is provided via special interfaces.
Prescription Use
David h. Sageman
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
§ 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).