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.

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
Automation Platform - SCAI-1PF

An individual software application intended to be installed on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of radiological images.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: LMD

Device Name: System, Digital Image Communications, Radiological

Device Class: 1

Physical State: N/A

Definition: A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, interfaces, and a communications protocol. 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.

Submission Type ID: 4

Review Panel: RA

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 892.2020

Third Party Flag: N

Medical Specialty: RA

Device Id: 04987670104329

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A