Automation Platform - This product is a software product that - CANON MEDICAL SYSTEMS CORPORATION

Duns Number:690575113

Device Description: This product is a software product that transfers, stores, converts formats, and displays This product is a software product that transfers, stores, converts formats, and displays medical device image data.It does not modify the image data or modify the display of the image data.This product reads images and interprets DICOM tags, analyzes pixels to identify body part and sequence type in order to categorize the images.This product is not intended to be used for active patient monitoring nor image interpretation.This product allows to route DICOM-compliant image data to and from automated post processing applications, but such processing applications are not a part of the platform itself.This product allows post processing applications to provide a notification or a flag intended to inform the user.

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More Product Details

Catalog Number

-

Brand Name

Automation Platform

Version/Model Number

SCAI-1PF

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

LMD

Product Code Name

System, Digital Image Communications, Radiological

Device Record Status

Public Device Record Key

b432a66b-5c48-441f-a00e-38f01891519a

Public Version Date

November 09, 2021

Public Version Number

1

DI Record Publish Date

November 01, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CANON MEDICAL SYSTEMS CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 200