K Number
K961753
Device Name
SHARED VISION(PART NUMBER SV 0015)
Manufacturer
Date Cleared
1996-07-25

(80 days)

Product Code
Regulation Number
892.2020
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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 Description
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. Both devices use a computer program to display a pre-digitized patient image file. Both devices nun 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.
More Information

Not Found

No
The description focuses on standard image display and processing with a proprietary algorithm, without mentioning AI/ML terms or capabilities.

No
The device is described as an "Image Display Software System" used for viewing and analyzing patient image data, not for treating conditions. Its function is diagnostic support, not therapy.

Yes

The device is designed to "allow physicians or other health care providers to remotely view and analyze patient Image Display data," which is a core function of a diagnostic tool used to interpret medical images for diagnosis.

Yes

The device is described as a "computerized, enhanced electronic Image Display Software System" and the description focuses solely on the software's function of displaying and analyzing pre-digitized image files using mathematical computations and algorithms within a computer operating system. There is no mention of any accompanying hardware components being part of the device itself.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
  • Device Function: The description clearly states that Shared Vision is an "Image Display Software System" designed to "remotely view and analyze patient Image Display data." It processes and displays pre-digitized patient image files from various imaging modalities (Cat Scanner, MRI, Radiographic, Fluoroscopy, Ultra Sound).
  • Lack of Biological Sample Analysis: There is no mention of the device analyzing biological samples from the patient. Its function is solely focused on the manipulation and display of medical images.

Therefore, Shared Vision falls under the category of medical imaging software, not an In Vitro Diagnostic device.

N/A

Intended Use / Indications for 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.

Product codes (comma separated list FDA assigned to the subject device)

90JAK, 90LNH, 90KPR, 90JAA, 90IYO

Device Description

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. Both devices use a computer program to display a pre-digitized patient image file. Both devices nun 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

physicians or other health care providers

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)

This device is safe and effective for the applications for which it is intended and has been tested to confirm safety and efficacy.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K936179

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 892.2020 Medical image communications device.

(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.

0

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

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.

1 25 1996

1961753

Product NomenclatureClassification NumberRegulation Number
Cat Scanner90JAK892.1750
MRI90LNH892.1000
Radiographic90KPR892.1680
Fluoroscopy90JAA892.1659
Ultra Sound90IYO892.1560

this device is a Class II device, having Classification Name, Monitor, Image Data,

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 nun 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.

Lisa Bergen
Ms. Lisa Bergen

Director, Product Services ImageLabs Incorporated 19A Crosby Drive, Suite 300 Bedford, MA 01803 Tel 617-271-1300 Fax 617-275-7737