SHARED VISION(PART NUMBER SV 0015)

K961753 · Imagelabs, Inc. · LMD · Jul 25, 1996 · Radiology

Device Facts

• Record ID: K961753
• Device Name: SHARED VISION(PART NUMBER SV 0015)
• Applicant: Imagelabs, Inc.
• Product Code: LMD · Radiology
• Decision Date: Jul 25, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2020
• Device Class: Class 1
• Attributes: Software as a Medical Device

Intended Use

Shared Vision is a computerized, enhanced electronic Image Display Software System designed for clinical applications to allow physicians or other health care providers to remotely view and analyze patient Image Display data. This system is suited for various computer networks.

Device Story

Shared Vision; computerized electronic image display software; enables remote viewing/analysis of patient image data (CT, MRI, Radiographic, Fluoroscopy, Ultrasound). Operates on computer networks; utilizes computer OS to access pre-digitized image files. Performs mathematical computations via proprietary algorithm to output display image resembling conventional image. Used by physicians/healthcare providers in clinical settings to facilitate diagnostic review. Benefits include remote access to patient data, supporting clinical decision-making.

Clinical Evidence

Bench testing only; device tested to confirm safety and efficacy; conforms to Good Manufacturing Procedures.

Technological Characteristics

Electronic image display software; runs on computer operating systems; utilizes proprietary algorithms and mathematical computations to process pre-digitized image files; network-compatible.

Indications for Use

Indicated for clinical applications allowing physicians or healthcare providers to remotely view and analyze patient image data from modalities including CT, MRI, Radiographic, Fluoroscopy, and Ultrasound.

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

• Winrad Teleradiology System (K936179)

Submission Summary (Full Text)

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Exhibit 16 Summary of Safety & Effectiveness for Shared Vision™ Image Display Software, Part Number SV 0015

K961753

Shared Vision is a computerized, enhanced electronic Image Display Software System designed for clinical applications to allow physicians or other health care providers to remotely view and analyze patient Image Display data. This system is suited for various computer networks.

JUL 25 1996

As such, this device is a Class II device, having Classification Name, Monitor, Image Data, described as:

| Product Nomenclature | Classification Number | Regulation Number |
| --- | --- | --- |
| Cat Scanner | 90JAK | 892.1750 |
| MRI | 90LNH | 892.1000 |
| Radiographic | 90KPR | 892.1680 |
| Fluoroscopy | 90JAA | 892.1659 |
| Ultra Sound | 90IYO | 892.1560 |

ImageLabs, Incorporated has determined that this device is substantially equivalent to a predicate medical device which is currently in commerce and has been submitted to the FDA via K936179 as an electronic Image Display Software and is identified as the Winrad Teleradiology System manufactured by Line Imaging Systems from Atlanta, GA. A determination of substantial equivalency is based upon:

Both the Shared Vision and Winrad Teleradiology System are electronic Image Display Software for clinical applications, to allow physicians or other health care providers to remotely view and analyze patient image data.

Both devices use a computer program to display a pre-digitized patient image file. Both devices run under a computer operating system. Both devices use the computer operating system to access the displayed image.

Both devices output a display image that resembles a conventional image. Both devices retain an electronically stored sample. Both act on that sample using mathematical computations. Both use a proprietary algorithm. Both use computer programming in a computer operating system.

Neither device has claims, or is offered as having the reproduction equivalent of a radiographic image.

Shared Vision has benefited from design, development, testing, and production procedures that conform to Good Manufacturing Procedures. This device has performance characteristics substantially equivalent to its predicate device yet includes improvements to facilitate the various clinical applications for which it is intended.

This device is safe and effective for the applications for which it is intended and has been tested to confirm safety and efficacy. ImageLabs Incorporated continues to search all appropriate sources for information relating to safety and effectiveness and maintains an in-house reporting system to identify adverse safety and effectiveness information and as such, applicable data is recorded for this product.

## CERTIFICATION

I hereby certify that this Summary of Safety and Effectiveness applies for the above indicated device.


Ms. Lisa Bergen
Director, Product Services
ImageLabs Incorporated
19A Crosby Drive, Suite 300
Bedford, MA 01803
Tel [phone]
Fax [phone]

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