(65 days)
Not Found
No
The document describes standard image processing techniques (multi planar reformatting, angiographic rendering, surface rendering, segmentation/disarticulation, cine display) and does not mention any AI or ML-specific terms or capabilities.
No.
The device is a workstation designed for reviewing and post-processing diagnostic images; it does not directly treat or diagnose a disease or condition.
No
The device is described as a workstation for reviewing and post-processing medical images, explicitly stating that "the indications for use remain unchanged from those defined for that modality" when used with diagnostic imaging modalities. This indicates it is a tool for viewing and manipulating images obtained from diagnostic devices, rather than being a diagnostic device itself.
No
The device description explicitly states that the MR Workstations integrate image review and processing software with a variety of hardware configurations, and it describes three major types of hardware configurations (ViStar, Montage, and OnCall).
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 examine specimens 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 this device is a workstation designed for the review and post-processing of digital images from various diagnostic imaging modalities (MR, CT, etc.). It does not involve the analysis of biological specimens.
- Intended Use: The intended use is to provide a platform for physicians to view and manipulate medical images for diagnostic purposes, not to perform tests on samples.
Therefore, this device falls under the category of medical imaging software and workstations, not In Vitro Diagnostics.
N/A
Intended Use / 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.
Product codes
Not Found
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 reformating capabilities described above. The Montage line of products are multi-monitor, multimodality viewing stations which have limited image manipulation and reformating capabilities. Finally, the OnCall systems are PC-based for remote viewing and provide image review and cine display.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR, CT, Nuclear Medicine, X-Ray, CR and Ultrasound
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
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
SUMMARY OF SAFETY AND EFFECTIVENESS
JUL - 3 1996
General Information 1.
| 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 | |
Intended Uses: 2.
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 reformating capabilities described above. The Montage line of products are multi-monitor, multimodality viewing stations which have limited image manipulation and reformating capabilities. Finally, the OnCall systems are PC-based for remote viewing and provide image review and cine display.
1
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.
| 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) |
| 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) |
| 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. | |
SUBSTANTIAL EQUIVALENCE CHART
PICKER INTERNATIONAL, INC. (MRWKST)
4/23/96
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PICKER INTERNATIONAL, INC. (MRWKST)
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4/24/96
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PICKER INTERNATIONAL, INC. (MRWKST) 4/23/96
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