D630 Upgrade H2401XF

GUDID 00840682145503

B615 to D630 upgrade kits option with new ROTOR

Hangwei GE Medical Systems Co., Ltd.

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• Primary Device ID: 00840682145503
• NIH Device Record Key: 3da7a092-90c2-4ed5-8d51-622af2e040c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: D630 Upgrade
• Version Model Number: H2401XF
• Catalog Number: H2401XF
• Company DUNS: 654659689
• Company Name: Hangwei GE Medical Systems Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682145503 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111445

FDA Product Code

• KPS: System, tomography, computed, emission

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: 2021-05-10
• Device Publish Date: 2021-04-30

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