NeuroQuant Brain Tumor

GUDID 00860000004824

CORTECHS LABS INC

MRI system application software

• Primary Device ID: 00860000004824
• NIH Device Record Key: 06e69f5a-6361-4bd0-bab7-8af4fe52f456
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeuroQuant Brain Tumor
• Version Model Number: NQ BT
• Company DUNS: 086086498
• Company Name: CORTECHS LABS INC
• Device Count: 1
• DM Exempt: true
• 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: true
• Serial Number: false
• Manufacturing Date: false
• 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	00860000004824 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210831

FDA Product Code

• QIH: Automated Radiological Image Processing Software

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: 2024-08-07
• Device Publish Date: 2024-07-30

Devices Manufactured by CORTECHS LABS INC

• 00860000004824 - NeuroQuant Brain Tumor: 2024-08-07
• 00860000004824 - NeuroQuant Brain Tumor: 2024-08-07
• 00863725000300 - NeuroQuant: 2020-02-05
• 00863725000317 - LesionQuant: 2020-02-05