THINQ

GUDID B801THINQ1000

CORTICOMETRICS LLC

Radiology DICOM image processing application software

• Primary Device ID: B801THINQ1000
• NIH Device Record Key: 81781fb3-4e59-44db-a2a2-34d9c52d77a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: THINQ
• Version Model Number: 1.0.0
• Company DUNS: 078509164
• Company Name: CORTICOMETRICS LLC
• 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: 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
HIBCC	B801THINQ1000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192051

FDA Product Code

• LLZ: System, Image Processing, Radiological

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: 2021-09-30
• Device Publish Date: 2021-09-22

On-Brand Devices [THINQ]

• B801THINQ1000: 1.0.0
• B801THINQ1130: 1.1.3