Atlas SPEEDER Spine

GUDID 04987670101441

Atlas SPEEDER Spine

CANON MEDICAL SYSTEMS CORPORATION

MRI system coil, radio-frequency

• Primary Device ID: 04987670101441
• NIH Device Record Key: eb09a6ae-769b-4c2f-9ad5-7fe406829725
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Atlas SPEEDER Spine
• Version Model Number: MJAS-147A
• Company DUNS: 690575113
• Company Name: CANON MEDICAL SYSTEMS CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• 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: +1-8004211968
• Email: xxx@xxx.xxx

Device Identifiers

Device Issuing Agency	Device ID
GS1	04987670101441 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063361

FDA Product Code

• LNH: System, nuclear magnetic resonance imaging

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-03-05
• Device Publish Date: 2016-09-01

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• 04987670106095 - Aquilion Serve SP: 2024-07-12
• 04987670100925 - BIOPSY ADAPTOR: 2024-04-22
• 04987670104626 - LINEAR ARRAY TRANSDUCER: 2024-04-22
• 04987670104633 - LINEAR ARRAY TRANSDUCER: 2024-04-22
• 04987670104640 - ENDOCAVITARY TRANSDUCER: 2024-04-22
• 04987670104664 - CONVEX ARRAY TRANSDUCER: 2024-04-22