NeuSight PET/CT Scanner System

GUDID 06970167440053

Neusoft Medical Systems Co., Ltd.

PET/CT system

• Primary Device ID: 06970167440053
• NIH Device Record Key: 3d42cf68-e119-4e56-be6a-36dc7594c6ad
• Commercial Distribution Discontinuation: 2018-06-14
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: NeuSight PET/CT Scanner System
• Version Model Number: NeuSight PET/CT 64
• 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	06970167440053 [Primary]

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: 3
• Public Version Date: 2018-06-15
• Device Publish Date: 2016-09-19

On-Brand Devices [NeuSight PET/CT Scanner System]

• 06970167440060: NeuSight PET/CT 16
• 06970167440053: NeuSight PET/CT 64