MITRA IMAGING, INC. FILM EXPRESS SCANNING SOFTWARE

K970652 · Mitra Imaging, Inc. · LMD · May 2, 1997 · Radiology

Device Facts

• Record ID: K970652
• Device Name: MITRA IMAGING, INC. FILM EXPRESS SCANNING SOFTWARE
• Applicant: Mitra Imaging, Inc.
• Product Code: LMD · Radiology
• Decision Date: May 2, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2020
• Device Class: Class 1
• Attributes: Software as a Medical Device

Intended Use

The intended user of this device is a DICOM software package that will enable any hospital PC with adequate monitor and enough memory to be used as a radiographic image viewer. It is designed to be utilized with Radiological-Quality scanners, such as the Lumisys, Lumiscan film digitizers, and other DICOM conformant devices such as CT scanners or clinical workstations.

Device Story

Film Express is a DICOM-compliant software package for hospital PCs; functions as a teleradiology system for viewing, archiving, and transmitting radiological images. Inputs include digital images from radiological-quality scanners (e.g., Lumisys film digitizers) or other DICOM-conformant devices (CT scanners). Software enables basic image review functions including flip, rotate, pan, and zoom. Operates on standard off-the-shelf PC hardware. Used by clinicians to facilitate remote image review and storage. Does not perform image processing; does not affect image quality. Supports JPEG compression with DICOM-standard identification. Facilitates clinical decision-making by providing access to radiological images across a network via TCP/IP.

Clinical Evidence

No clinical data. Bench testing performed by programmers, non-programmers, and potential customers to validate software functionality. Software does not perform image processing and has no bearing on image quality.

Technological Characteristics

Software-only PACS/teleradiology system. Operates on standard off-the-shelf PC hardware. Connectivity via TCP/IP. Supports DICOM standard for image transmission and storage. Features include JPEG compression, DICOM basic printing, and image manipulation (flip, rotate, pan, zoom). Display resolution 1024x768.

Indications for Use

Indicated for use as a teleradiology system for the viewing, archiving, and transmission of radiological images in a hospital setting.

Regulatory Classification

Identification

A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, and interfaces. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions. This does not include electronic transfer of medical image software functions.

Predicate Devices

• Lumisys DICOM TOOLKIT
• Imageshare 910
• Statview
• Dejarnette, Imageshare 910 Film Digitizing Acquisition Station

Submission Summary (Full Text)

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K970652

# 510(k) SUMMARY

1.1 Company Identification

MAY - 2 1997

Mitra Imaging, Inc.
115 Randal Dr.
Waterloo, Ontario, Canada
N2V 1C5
Tel: [phone]
Fax: [phone]

1.2 Official Correspondent

Gary J. Allsebrook
Regulatory Management Services
16303 Panoramic Way
San Leandro, CA, USA, 94578-1116

1.3 Date of Submission

February 21, 1997

1.4 Device Name

Classification Name: PACS

Common/Usual Name: Teleradiology System

Proprietary Name: Film Express

1.5 Substantial Equivalence

The Film Express software is substantially equivalent to the Lumisys DICOM TOOLKIT, Imageshare 910, or Statview.

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## 1.6 Device Description and Intended Use

The intended user of this device is a DICOM software package that will enable any hospital PC with adequate monitor and enough memory to be used as a radiographic image viewer. It is designed to be utilized with Radiological-Quality scanners, such as the Lumisys, Lumiscan film digitizers, and other DICOM conformant devices such as CT scanners or clinical workstations.

## 1.7 Software Development

Mitra certifies that the Film Express 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. The software used in this product is used for teleradiology and/or storage only and does not affect image quality.

## 1.8 Substantial Equivalence Comparison Chart

Substantial Equivalence Comparison Chart (Film Express)

| Specification | Film Express | DICOM Toolkit | Imageshare/FD (910) | Statview/DX |
| --- | --- | --- | --- | --- |
| Graphical User Interface | Yes | Yes | No | Yes |
| Scanners Supported | Radiological Quality scanners, such as Lumisys 20/50/75/85/100/150/200 | 50, 75, 150, 200 | 50, 75, 100, 150, 200 | 50, 75, 100 |
| Patient Demographics | Yes | Yes | Yes | Yes |
| Display Resolution | 1024x768 | 1024x768 | N/A | 800x600, 1024x768, 1280x1024, 1200x1600 |
| Communications | TCP/IP | TCP/IP | TCP/IP | TCP/IP |
| Image Review | Flip/Rotate/Pan/Zoom | Flip/Rotate/Pan/Zoom | Flip/Rotate | Flip/Rotate/Pan/Zoom |
| Temporary Image Storage | Yes | Yes | Yes | Yes |
| Platform | PC | PC | PC | PC |
| JPEG | Yes | No | Yes | No |
| DICOM Basic Printing | Yes | No | No | No |

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1.9 Safety and Effectiveness

In accordance with the provisions of the Safe Medical Device Act of 1990, Mitra Imaging, Inc. is providing a summary of safety and effectiveness information regarding the Film Express software.

General Safety and Effectiveness Concerns:

The device labeling contains instructions for use and indication for use.

The hardware components specified (but not supplied) are all "off the shelf" computer components.

Validation and Effectiveness:

Extensive testing of the software package has been performed by programmers, by non-programmers, and by potential customers. Software is only used for control purposes and has no bearing on image quality. There is no image processing used with this software.

Images 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.

Substantial Equivalence:

The Film Express software is a software package used for archiving and transmission of radiological images. The intended use and technological characteristics of the system are similar to the Dejarnette, Imageshare 910 Film Digitizing Acquisition Station. Any differences between the Film Express software and the equivalent device have no significant influence on safety or effectiveness.

It is our conclusion that there is no software component that we know of in the Film Express software whose failure or latent design flaw would be expected to result in death or injury to a patient.