TrueView

GUDID 06974970580081

The TrueView Core 100Pro-US Core Specimen Radiography System (CSRS) is a Cabinet X-ray System intended to provide the detailed radiographic imaging of small surgical excised or biopsy specimens and to further provide rapid verification that correct tissue has been excised.

CompAI Healthcare (Suzhou) Co.,ltd

Tissue specimen x-ray system IVD

• Primary Device ID: 06974970580081
• NIH Device Record Key: d332857f-1a94-4ab7-bc8b-15c29e04ab41
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TrueView
• Version Model Number: Core 100Pro-US
• Company DUNS: 554545203
• Company Name: CompAI Healthcare (Suzhou) 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06974970580081 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230140

FDA Product Code

• MWP: Cabinet, X-Ray System

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: 2023-05-25
• Device Publish Date: 2023-05-17

On-Brand Devices [TrueView]

• 06974970580081: The TrueView Core 100Pro-US Core Specimen Radiography System (CSRS) is a Cabinet X-ray System in
• 06974970580074: The TrueView 200 Pro-US is a Cabinet X-ray System intended to provide the detailed radiographic