(63 days)
No
The document describes a PACS system for image storage, distribution, viewing, and basic processing, but makes no mention of AI or ML capabilities.
No
The device is described as a system for distributing, viewing, and processing medical images and reports. It does not perform any direct treatment, diagnosis, or modification of the body's structure or function, which are characteristics of a therapeutic device. Its function is to manage and display medical data for healthcare professionals.
No
Visage PACS/CS is a system for distributing, viewing, and processing medical images and reports, specifically designed for archiving and accessing medical image data, not for providing diagnostic interpretations or conclusions.
Yes
The device is described as a system consisting of software components (Storage, Web, CS) for distributing, viewing, and processing medical images and reports. While it interacts with hardware (servers, workstations, modalities), the device itself is presented as a software system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The description clearly states that Visage PACS/CS is a system for distributing, viewing, and processing medical images and reports. It handles image data from various scanning modalities.
- Lack of Biological Sample Analysis: There is no mention of the device analyzing biological samples or performing any tests on bodily fluids or tissues. Its function is centered around the management and display of medical images.
Therefore, Visage PACS/CS falls under the category of medical imaging software or a Picture Archiving and Communication System (PACS), not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
90 LLZ
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: 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Multi Modality (CR, CT, DR, DS, DX, ES, GM, IO, MG, MR, NM, PT, OT, RF, RT, US, XA, XC)
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained and instructed health care professionals / within and outside health care environments, doctor's office, hospitals, physician's home.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
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
1
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
2
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 |
| for the application of ISO 9001 |
3
| 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 |
4
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".
5
| Substantial Equivalence comparison Chart | |||
|---|---|---|---|
| -- | -- | ------------------------------------------ | -- |
| Product | Visage PACS/CS
4.1 | AquariusNet
Server/Thin client | RADIN 3.0 |
|------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Name | Mercury Computer
Systems, Inc. | TeraRecon, Inc. | Mercury Computer
Systems, Inc.
Formally SoHard
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,
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
Management | | | |
| Intelligent storage
management | Yes | Yes | Yes |
| Data Storage | | | |
| Device | | | |
| RAID, SAN, NAS | 250GB to several
TB | RAID, SAN, NAS | |
| DICOM Network | | | |
| DICOM Confor-
mance | DICOM 3.0 | DICOM 3.0 | DICOM 3.0 |
| Hardware and Soft-
ware Requirements
for server | | | |
| Hardware
Software | PC 2x Pentium III
1,4 GHz or PC 1x
Pentium IV 3GHz
(Hyperthreading),
= 1GB RAM
2x 60 GB Harddisk
SCSI or SATA
Windows
2003 | Workstation
Latest
Dell Power Solution
VolumePro
(Ter-
Graphics
rarecon)
Board,
Pentium
4
Intel
processor, 2.0 GHz
or faster
512MB of SDRAM
system memory
120GB Hard
Disk
Drive storage
Windows
NT
4.0. | PC
111,
Pentium
min 500MHz
512 MB RAM
20 GB Harddisk
Windows
2003 |
| | Server
Internet Explorer 6 | Windows 2000, Win
2003 | Server
Internet Explorer 6 |
| Workflow Features | | | |
| DICOM report inter-
face | Yes | Yes | Yes |
| File based report
interface | Yes | Yes | Yes |
| URL interface for
OEM integration | Yes | Yes | Yes |
| Creation of patient
media (DVD) ac-
cording to DICOM
standard | Yes | Yes | Yes |
| | Visage PACS/CS
3D Server | | |
| Scalability | Yes | Yes | Yes |
| Data Storage For-
mat | | | |
| Volume Data | Yes | Yes | |
| Hardware and Soft-
ware Requirements | | | |
| Hardware | Minimum 2x dual
core Opteron, 8GB
RAM, graphic
adapter 2x
FX4500, 1x 160GB
Harddisk | Workstation Latest
Dell Power Solution
VolumePro (Terare-
con) Graphics
Board,
Pentium 4 Intel
processor, 2.0 GHz
or faster
512MB of SDRAM
system memory
120GB Hard Disk
Drive storage | Pentium 2 GHz
512 MB RAM
50-100 GB Hard-
disk |
| Software | SuSe Linux version
10.0 | Windows NT 4.0,
Windows 2000, Win
2003 | Windows 2003
Server
Internet Explorer 6 |
| Workflow Features | | | |
| URL interface for
OEM integration | Yes | Yes, added capabil-
ity | Yes |
| | Visage PACS/CS
Archive | | |
| Storage Modules | | | |
| Harddisk RAID | Yes | Yes | |
| SAN systems | Yes | Yes | |
| NAS systems | Yes | Yes | |
| Data Security | | | |
| Data verification on
media | Yes | No | Yes |
| Manipulation detec-
tion | Yes | No | Yes |
| Database consis-
tency check | Yes | No | Yes |
| Archive type | PACS | PACS or UNC
mount point storage | PACS |
| Hardware and Soft-
ware Requirements | | | |
| Hardware | Pentium 2 GHz
512 MB RAM
50-100 GB Hard-
disk | Standard Dell High
Performance Prod-
uct | |
| Software | Windows 2003
Server
Internet Explorer 6 | Windows NT 4.0,
Windows 2000 | |
| | Visage PACS/CS
WEB Client | | |
| Key Features | | | |
| Full DICOM images
on clients | Yes | Yes | No |
| No Software Installa-
tion, just Internet
Explorer needed | Yes | No, thin client also
for 2D part. Also
has activeX client
that can run within
IE and does not
require client
download. | 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 Image
Types | | | |
| Greyscale, Color,
Multiframe | Yes | Yes | Yes |
| Image Manipulation
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
Functions | | | |
| Distance | Yes | Yes | Yes |
| Angulation | Yes | Yes | Yes |
| Area | Yes | Yes | Yes |
| Greyscale densitiy
(probe) | Yes | Yes | Yes |
| Manual distance
calibration | Yes | Yes | Yes |
| Cine Mode | Yes | Yes | Yes |
| Workflow features | | | |
| Database Filters | Yes | Yes | Yes |
| DICOM
query/retrieve from
archives and work-
stations | Yes | Yes | Yes |
| Change user and
group assignment of
patients | Yes | Yes | Yes |
| Multiple series load-
ing | Yes | Yes | Yes |
| Preloading of im-
ages to the client | Yes | No - Not needed | Yes |
| Study availability
status | Yes | No - if study is in
the worklist it is
available. Load
time from PACS
archive for 500 im-
age CT dataset is