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 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