Automation Platform

GUDID 04987670104329

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.

CANON MEDICAL SYSTEMS CORPORATION

Radiology PACS software
Primary Device ID04987670104329
NIH Device Record Keyb432a66b-5c48-441f-a00e-38f01891519a
Commercial Distribution StatusIn Commercial Distribution
Brand NameAutomation Platform
Version Model NumberSCAI-1PF
Company DUNS690575113
Company NameCANON MEDICAL SYSTEMS CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8005211968
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Phone8005211968
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Phone8005211968
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Phone8005211968
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Phone8005211968
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Phone8005211968
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Phone8005211968
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Phone8005211968
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Phone8005211968
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Phone8005211968
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Phone8005211968
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Phone8005211968
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Phone8005211968
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Phone8005211968
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Phone8005211968
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Phone8005211968
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Phone8005211968
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Phone8005211968
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Phone8005211968
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Phone8005211968
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Phone8005211968
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Device Identifiers

Device Issuing AgencyDevice ID
GS104987670104329 [Primary]

FDA Product Code

LMDSystem, Digital Image Communications, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-11-09
Device Publish Date2021-11-01

Devices Manufactured by CANON MEDICAL SYSTEMS CORPORATION

04987670104541 - DIAGNOSTIC ULTRASOUND SYSTEM2024-07-15
04987670104558 - DIAGNOSTIC ULTRASOUND SYSTEM2024-07-15
04987670106095 - Aquilion Serve SP2024-07-12
04987670100925 - BIOPSY ADAPTOR2024-04-22
04987670104626 - LINEAR ARRAY TRANSDUCER2024-04-22
04987670104633 - LINEAR ARRAY TRANSDUCER2024-04-22
04987670104640 - ENDOCAVITARY TRANSDUCER2024-04-22
04987670104664 - CONVEX ARRAY TRANSDUCER2024-04-22

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