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 ID: 04987670104329
• NIH Device Record Key: b432a66b-5c48-441f-a00e-38f01891519a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Automation Platform
• Version Model Number: SCAI-1PF
• Company DUNS: 690575113
• Company Name: CANON MEDICAL SYSTEMS CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8005211968
• Email: xxx@xxx.xxx
• Phone: 8005211968
• Email: xxx@xxx.xxx
• Phone: 8005211968
• Email: xxx@xxx.xxx
• Phone: 8005211968
• Email: xxx@xxx.xxx
• Phone: 8005211968
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• Phone: 8005211968
• Email: xxx@xxx.xxx
• Phone: 8005211968
• Email: xxx@xxx.xxx
• Phone: 8005211968
• Email: xxx@xxx.xxx
• Phone: 8005211968
• Email: xxx@xxx.xxx
• Phone: 8005211968
• Email: xxx@xxx.xxx
• Phone: 8005211968
• Email: xxx@xxx.xxx
• Phone: 8005211968
• Email: xxx@xxx.xxx
• Phone: 8005211968
• Email: xxx@xxx.xxx
• Phone: 8005211968
• Email: xxx@xxx.xxx
• Phone: 8005211968
• Email: xxx@xxx.xxx
• Phone: 8005211968
• Email: xxx@xxx.xxx
• Phone: 8005211968
• Email: xxx@xxx.xxx
• Phone: 8005211968
• Email: xxx@xxx.xxx
• Phone: 8005211968
• Email: xxx@xxx.xxx
• Phone: 8005211968
• Email: xxx@xxx.xxx
• Phone: 8005211968
• Email: xxx@xxx.xxx
• Phone: 8005211968
• Email: xxx@xxx.xxx
• Phone: 8005211968
• Email: xxx@xxx.xxx
• Phone: 8005211968
• Email: xxx@xxx.xxx
• Phone: 8005211968
• Email: xxx@xxx.xxx
• Phone: 8005211968
• Email: xxx@xxx.xxx
• Phone: 8005211968
• Email: xxx@xxx.xxx
• Phone: 8005211968
• Email: xxx@xxx.xxx
• Phone: 8005211968
• Email: xxx@xxx.xxx
• Phone: 8005211968
• Email: xxx@xxx.xxx
• Phone: 8005211968
• Email: xxx@xxx.xxx
• Phone: 8005211968
• Email: xxx@xxx.xxx

Device Identifiers

Device Issuing Agency	Device ID
GS1	04987670104329 [Primary]

FDA Product Code

• LMD: System, Digital Image Communications, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-11-09
• Device Publish Date: 2021-11-01

Devices Manufactured by CANON MEDICAL SYSTEMS CORPORATION

• 04987670104374 - ULTRASOUND IMAGE ANALYSIS PROGRAM UltraExtend NX CUW-U001S: 2025-07-10
• 04987670103216 - CONVEX ARRAY TRANSDUCER: 2025-04-09
• 04987670100079 - CATHETERIZATION TABLE: 2025-03-21
• 04987670100345 - X-RAY FLAT PANEL DETECTOR: 2025-03-11
• 04987670104312 - X-RAY FLAT PANEL DETECTOR: 2025-03-11
• 04987670104121 - Aquilion Exceed LB: 2025-01-22
• 04987670105579 - Aquilion ONE: 2025-01-17
• 04987670104541 - DIAGNOSTIC ULTRASOUND SYSTEM: 2024-07-15