PICKER MR WORKSTATIONS (VISTAR,MONTAGE AND ONCALL)

K961637 · Philips Medical Systems (Cleveland), Inc. · LLZ · Jul 3, 1996 · Radiology

Device Facts

• Record ID: K961637
• Device Name: PICKER MR WORKSTATIONS (VISTAR,MONTAGE AND ONCALL)
• Applicant: Philips Medical Systems (Cleveland), Inc.
• Product Code: LLZ · Radiology
• Decision Date: Jul 3, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Indications for Use

The MR Workstations (including the ViStar, Montage and OnCall) are designed to provide fast and convenient review of DICOM compatible digital images from all six diagnostic imaging modalities (MR, CT, Nuclear Medicine, X-Ray, CR and Ultrasound) and secondary capture as well as post-processing of MR and CT images including multi planar reformatting, angiographic rendering, surface rendering, segmentation/disarticulation and cine display. When used in conjunction with any of these diagnostic imaging modalities, the indications for use remain unchanged from those defined for that modality.

Device Story

MR Workstations (ViStar, Montage, OnCall) function as image viewing and processing systems for DICOM-compatible digital images. Inputs include MR, CT, Nuclear Medicine, X-Ray, CR, and Ultrasound data. The system transforms these inputs via software-based post-processing, including multi-planar reformatting, angiographic rendering, surface rendering, segmentation/disarticulation, and cine display. ViStar systems are single-monitor workstations; Montage systems are multi-monitor, multi-modality stations; OnCall systems are PC-based for remote viewing. Operated by clinicians in clinical settings, the device provides visual output on high-resolution monitors. Healthcare providers use these outputs to review diagnostic images and perform image manipulation, facilitating clinical decision-making by providing enhanced visualization of soft tissue structures and diagnostic data.

Clinical Evidence

No clinical data provided. Bench testing only.

Technological Characteristics

Hardware includes DEC/Alpha RISC-based workstations (ViStar/Montage) and Pentium-class PCs (OnCall). RAM ranges from 24-256 MB. Connectivity via Ethernet TCP/IP supporting DICOM v3.0. Monitors include 17-21" high-resolution (1280x1024) color/greyscale displays. Software provides graphical user interface for image review, database management, and post-processing (reformatting, rendering, segmentation).

Indications for Use

Indicated for review and post-processing of DICOM-compatible diagnostic images (MR, CT, Nuclear Medicine, X-Ray, CR, Ultrasound) to assist trained physicians in diagnosis. Patient population is defined by the primary imaging modality used in conjunction with the workstation.

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

• ViStar (K905070)
• EDGE/VISTA systems (K931544)

Submission Summary (Full Text)

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K96/637

# SUMMARY OF SAFETY AND EFFECTIVENESS

JUL - 3 1996

## 1. General Information

Classification: Class II
Image Processing System

Common/Usual Name: Image Viewing and Processing Workstation

Proprietary Name: MR Workstations (ViStar, Montage and OnCall)

Establishment Registration: Picker International, Inc.
World Headquarters
595 Miner Road
Cleveland, Ohio 44143
FDA Owner Number: #1580240
FDA Registration Number: #1525965

Performance Standards: Not Applicable

## 2. Intended Uses:

The MR Workstations (including the ViStar, Montage and OnCall) are designed to provide fast and convenient review of DICOM compatible digital images from all six diagnostic imaging modalities (MR, CT, Nuclear Medicine, X-Ray, CR and Ultrasound) and secondary capture as well as post-processing of MR and CT images including multi planar reformatting, angiographic rendering, surface rendering, segmentation/disarticulation and cine display.

When used in conjunction with any of these diagnostic imaging modalities, the indications for use remain unchanged from those defined for that modality.

## 3. Device Description:

The Picker MR Workstations (ViStar, Montage and OnCall) integrate image review and processing software with a variety of hardware configurations. The software consists of a graphical user interface and post-processing capabilities for MR and CT images including: multi planar reformatting, angiographic rendering, surface rendering, segmentation / disarticulation and cine display. The hardware configurations can be divided into three major types, ViStar, Montage and Oncall. In general, the ViStar line of products are single-monitor workstations which can be equipped with all of the image manipulation and reformatting capabilities described above. The Montage line of products are multi-monitor, multi-modality viewing stations which have limited image manipulation and reformatting capabilities. Finally, the OnCall systems are PC-based for remote viewing and provide image review and cine display.

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# 4. Safety and Effectiveness

The Picker MR Workstations (ViStar, Montage and OnCall) are substantially equivalent to the ViStar (K905070) and the software described with the EDGE/VISTA systems (K931544) in safety and effectiveness. The following chart has been compiled to demonstrate the MR Workstations' substantial equivalence to these devices.

## SUBSTANTIAL EQUIVALENCE CHART

| Parameter | MR Workstations (ViStar/Montage/OnCall) | Predicate Device (ViStar K905070, EDGE/VISTA K931544) |
| --- | --- | --- |
| Computer | ViStar/Montage: DEC/Alpha supecomputer with RISC architecture.
OnCall: Pentium class personal computer platform (e.g. IBM Thinkpad 760C) | Stardent 3000 supercomputer using parallel RISC architecture. (K905070) |
| RAM Memory | ViStar/Montage: Ranges from 32 to 256 MBytes. Expandable for all models.
OnCall: 24 MBytes. Expandable to 64 MBytes. | 64 MBytes. Expandable to 128 MBytes. (K905070) |
| Image Storage Capabilities | ViStar/Montage: Disk storage ranges from 0.5 to 2.1 GBytes, Additional Storage, optical disk drive, VCR Interface and 1/2" streaming tape drive available.
OnCall: Minimum 760 MBytes of Disk Storage. | 760 MBytes disk storage, 1/4" cartridge tape drive, magnetic tape drive. Optional optical disk drive. (K905070) |

PICKER INTERNATIONAL, INC. (MRWKST)
4/23/96
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| Parameter | MR Workstations (ViStar/Montage/OnCall) | Predicate Device (ViStar K905070, EDGE/VISTA K931544) |
| --- | --- | --- |
| Networking | Ethernet TCP/IP. Supports the DICOM v3.0 imaging/networking protocols. | Ethernet TCP/IP. (K905070) |
| Filming | ViStar/Montage: Direct and Remote Filming Capabilities.
OnCall: Limited formats available. | Direct and Remote Filming Capabilities. (K905070) |
| Monitor | ViStar/Montage: 17-21" color or greyscale high resolution (1280 x 1024) monitor. 72 Hz, non-interlaced.
OnCall: Laptop- Color display with 800 x 600 resolution and SVGA graphics. Desktop- same as ViStar/Montage. | 19 inch, 1280 x 1024 high resolution color monitor, 60 Hz, non-interlaced. (K905070) |
| Graphical Interface | Image review, Database Directory, Draw, Filter, and Filming. | Image review, Database Directory, Draw, Filter, and Filming. (K931544) |
| Image Utilities | Archive, Delete, CD Player, CT Import, HPQ Import, HPQ Tape Import, Export, Camera Summary, Film Summary, Log Problem, Image Processing, Video Review, Video Capture, System Analysis, | Archive, Delete, Camera Summary, HPQ Import (K931544) |

PICKER INTERNATIONAL, INC. (MRWKST)
4/24/96
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| Parameter | MR Workstations (ViStar/Montage/OnCall) | Predicate Device (ViStar K905070, EDGE/VISTA K931544) |
| --- | --- | --- |
| Image Manipulation & Reformatting Capabilities | ViStar: Cine Display, Multi planar Reformatting, Angiographic Rendering, Surface Rendering & Cubeview, Segmentation / Disarticulation (Optional).

Montage: Cine Display, Multi planar Reformatting, Angiographic Rendering (Optional).

OnCall: Cine Display. | Cine Display, Multi planar Reformatting, Angiographic Rendering, Surface Rendering & Cubeview. (K905070) |
| Intended Use | The ViStar systems used with HPQ and 2055HP systems do not change the existing indications which are: The Picker International Vista HPQ and 2055 HP systems are indicated for use as NMR devices that produce images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1), and spin-spin relaxation time (T2)) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis. (K905070)

The Picker MR Workstations (including the ViStar, Montage and OnCall) are designed to provide fast and convenient review of DICOM compatible digital images from all six diagnostic imaging modalities (MR, CT, Nuclear Medicine, X-Ray, CR and Ultrasound) and secondary capture as well as post-processing of MR and CT images including multi planar reformatting, angiographic rendering, surface rendering, segmentation/disarticulation and cine display. When used in conjunction with any of these diagnostic imaging modalities, the indications for use remain unchanged from those defined for that modality. | |

PICKER INTERNATIONAL, INC. (MRWKST)

4/23/96