NeuViz 64 Multi-slice CT Scanner System

GUDID 06970167440039

Neusoft Medical Systems Co., Ltd.

Full-body CT system

• Primary Device ID: 06970167440039
• NIH Device Record Key: 8be426cc-25cd-4dbe-ab5e-5e65f7667bc3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeuViz 64 Multi-slice CT Scanner System
• Version Model Number: NeuViz 64 En
• Company DUNS: 724421537
• Company Name: Neusoft Medical Systems Co., Ltd.
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970167440039 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121792

FDA Product Code

• JAK: System, X-Ray, Tomography, Computed

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-19

On-Brand Devices [NeuViz 64 Multi-slice CT Scanner System]

• 06970167440039: NeuViz 64 En
• 06970167440022: NeuViz 64 In
• 06970167440015: NeuViz 64e
• 06970167440008: NeuViz 64i