NeuroQ

GUDID B133NEUROQ1

NeuroQ™ has been developed to aid in the assessment of human brain scans through quantification of mean pixel values lying within standardized regions

SYNTERMED INCORPORATED

Neurosurgical ultrasound navigation system application software

• Primary Device ID: B133NEUROQ1
• NIH Device Record Key: 363ace02-fe2c-4886-8d7d-037333dc681e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeuroQ
• Version Model Number: 3.75.20171019
• Company DUNS: 113727205
• Company Name: SYNTERMED INCORPORATED
• 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	B133NEUROQ1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130451

FDA Product Code

• KPS: System, Tomography, Computed, Emission

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: 2018-07-30
• Device Publish Date: 2018-06-29

On-Brand Devices [NeuroQ]

• B133NEUROQ1: NeuroQ™ has been developed to aid in the assessment of human brain scans through quantificatio
• B133NEUROQ0: NeuroQ™ has been developed to aid in the assessment of human brain scans through quantificatio
• B133NEUROQ382104290: NeuroQ™ has been developed to aid in the assessment of human brain scans through quantificatio
• B133NEUROQ382112070: NeuroQ™ has been developed to aid in the assessment of human brain scans through quantificatio