VISAGE PACS/CS, RELEASE VERSION 4.1

K062490 · Mercury Computer Systems, Inc. · LLZ · Oct 27, 2006 · Radiology

Device Facts

• Record ID: K062490
• Device Name: VISAGE PACS/CS, RELEASE VERSION 4.1
• Applicant: Mercury Computer Systems, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Oct 27, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

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.

Device Story

Visage PACS/CS is a medical image management system for distributing, viewing, and processing images/reports. Components include Visage PACS Storage (DICOM server for archiving), Visage PACS Web (web-based 2D viewing), and Visage CS (thin-client 3D visualization). Input: DICOM images from scanning modalities via hospital network. Operation: Server stores/manages data; Visage CS streams compressed screen content to thin clients, keeping DICOM data on the server. Used in clinical environments/remote locations by physicians/staff. Output: Visualized 2D/3D images and reports on web browsers or thin clients. Supports clinical decision-making by providing diagnostic-quality images; final diagnosis remains the responsibility of the physician. Benefits: Enables remote access to large 3D datasets and integrated 2D/3D workflow across hospital enterprises.

Clinical Evidence

Bench testing only. The device underwent hazard analysis, verification, and validation testing according to the manufacturer's software development process. Integration and system-level testing were performed to confirm hazard mitigation. No clinical data was required or provided.

Technological Characteristics

Software-based PACS/CS running on general-purpose PC hardware (Windows 2003 Server). Connectivity via TCP/IP and DICOM 3.0. Supports RAID, SAN, and NAS storage. 3D visualization via thin-client streaming of compressed screen content. Security via SSL encryption and VPN. Software development follows ISO 9001:2000, ISO 13485:2003, and 21 CFR 820.

Indications for Use

Indicated for use by trained healthcare professionals for the distribution, viewing, and processing of medical images and reports within and outside healthcare environments. Contraindications: Mammographic images compressed by lossy methods and digitized film screen images must not be reviewed for primary image interpretations.

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).

Predicate Devices

• TeraRecon AquariusNet Server/Thin client (K012086)

Reference Devices

• RADIN 3.0 (K043483)

Submission Summary (Full Text)

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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.: [phone] Fax: [phone] E-Mail: [e-mail]

### 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 requirements<br>for 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<br>(IEC) 60601-1-4<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | 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/CS<br>4.1 | AquariusNet<br>Server/Thin client | RADIN 3.0 |
|------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Name | Mercury Computer<br>Systems, Inc. | TeraRecon, Inc. | Mercury Computer<br>Systems, Inc.<br>Formally SoHard<br>AG |
| 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,<br>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 Space<br>Management | | | |
| Intelligent storage<br>management | Yes | Yes | Yes |
| Data Storage | | | |
| Device | | | |
| RAID, SAN, NAS | 250GB to several<br>TB | RAID, SAN, NAS | |
| DICOM Network | | | |
| DICOM Confor-<br>mance | DICOM 3.0 | DICOM 3.0 | DICOM 3.0 |
| Hardware and Soft-<br>ware Requirements<br>for server | | | |
| Hardware<br>Software | PC 2x Pentium III<br>1,4 GHz or PC 1x<br>Pentium IV 3GHz<br>(Hyperthreading),<br>>= 1GB RAM<br>2x 60 GB Harddisk<br>SCSI or SATA<br>Windows<br>2003 | Workstation<br>Latest<br>Dell Power Solution<br>VolumePro<br>(Ter-<br>Graphics<br>rarecon)<br>Board,<br>Pentium<br>4<br>Intel<br>processor, 2.0 GHz<br>or faster<br>512MB of SDRAM<br>system memory<br>120GB Hard<br>Disk<br>Drive storage<br>Windows<br>NT<br>4.0. | PC<br>111,<br>Pentium<br>min 500MHz<br>512 MB RAM<br>20 GB Harddisk<br>Windows<br>2003 |
| | Server<br>Internet Explorer 6 | Windows 2000, Win<br>2003 | Server<br>Internet Explorer 6 |
| Workflow Features | | | |
| DICOM report inter-<br>face | Yes | Yes | Yes |
| File based report<br>interface | Yes | Yes | Yes |
| URL interface for<br>OEM integration | Yes | Yes | Yes |
| Creation of patient<br>media (DVD) ac-<br>cording to DICOM<br>standard | Yes | Yes | Yes |
| | Visage PACS/CS<br>3D Server | | |
| Scalability | Yes | Yes | Yes |
| Data Storage For-<br>mat | | | |
| Volume Data | Yes | Yes | |
| Hardware and Soft-<br>ware Requirements | | | |
| Hardware | Minimum 2x dual<br>core Opteron, 8GB<br>RAM, graphic<br>adapter 2x<br>FX4500, 1x 160GB<br>Harddisk | Workstation Latest<br>Dell Power Solution<br>VolumePro (Terare-<br>con) Graphics<br>Board,<br>Pentium 4 Intel<br>processor, 2.0 GHz<br>or faster<br>512MB of SDRAM<br>system memory<br>120GB Hard Disk<br>Drive storage | Pentium 2 GHz<br>512 MB RAM<br>50-100 GB Hard-<br>disk |
| Software | SuSe Linux version<br>10.0 | Windows NT 4.0,<br>Windows 2000, Win<br>2003 | Windows 2003<br>Server<br>Internet Explorer 6 |
| Workflow Features | | | |
| URL interface for<br>OEM integration | Yes | Yes, added capabil-<br>ity | Yes |
| | Visage PACS/CS<br>Archive | | |
| Storage Modules | | | |
| Harddisk RAID | Yes | Yes | |
| SAN systems | Yes | Yes | |
| NAS systems | Yes | Yes | |
| Data Security | | | |
| Data verification on<br>media | Yes | No | Yes |
| Manipulation detec-<br>tion | Yes | No | Yes |
| Database consis-<br>tency check | Yes | No | Yes |
| Archive type | PACS | PACS or UNC<br>mount point storage | PACS |
| Hardware and Soft-<br>ware Requirements | | | |
| Hardware | Pentium 2 GHz<br>512 MB RAM<br>50-100 GB Hard-<br>disk | Standard Dell High<br>Performance Prod-<br>uct | |
| Software | Windows 2003<br>Server<br>Internet Explorer 6 | Windows NT 4.0,<br>Windows 2000 | |
| | Visage PACS/CS<br>WEB Client | | |
| Key Features | | | |
| Full DICOM images<br>on clients | Yes | Yes | No |
| No Software Installa-<br>tion, just Internet<br>Explorer needed | Yes | No, thin client also<br>for 2D part. Also<br>has activeX client<br>that can run within<br>IE and does not<br>require client<br>download. | Yes |
| Supported Modali-<br>ties | CR, CT, DR, DS,<br>DX, ES, GM, IO,<br>MG, MR, NM, PT,<br>OT, RF, RT, US,<br>XA, XC | CR,CT,MR,DR, US,<br>PT, NM, DX, OT,<br>RF, SC, XF, XA | CR, CT, DR, DS,<br>DX, ES, GM, IO,<br>MG, MR, NM, PT,<br>OT, RF, RT, US,<br>XA, XC |
| Supported Image<br>Types | | | |
| Greyscale, Color,<br>Multiframe | Yes | Yes | Yes |
| Image Manipulation<br>Functions | | | |
| 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 |
| Measurement<br>Functions | | | |
| Distance | Yes | Yes | Yes |
| Angulation | Yes | Yes | Yes |
| Area | Yes | Yes | Yes |
| Greyscale densitiy<br>(probe) | Yes | Yes | Yes |
| Manual distance<br>calibration | Yes | Yes | Yes |
| Cine Mode | Yes | Yes | Yes |
| Workflow features | | | |
| Database Filters | Yes | Yes | Yes |
| DICOM<br>query/retrieve from<br>archives and work-<br>stations | Yes | Yes | Yes |
| Change user and<br>group assignment of<br>patients | Yes | Yes | Yes |
| Multiple series load-<br>ing | Yes | Yes | Yes…