NeuViz 128 Multi-Slice CT Scanner System

GUDID 06970167441616

Neusoft Medical Systems Co., Ltd.

Full-body CT system

• Primary Device ID: 06970167441616
• NIH Device Record Key: 580a8b5f-3ff0-4caa-b0cb-e850f12d088c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeuViz 128 Multi-Slice CT Scanner System
• Version Model Number: NeuViz 128
• 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	06970167441616 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230220

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-31
• Device Publish Date: 2023-10-23

On-Brand Devices [NeuViz 128 Multi-Slice CT Scanner System]

• 06970167440046: NeuViz 128
• 06970167441616: NeuViz 128