TeraRecon Neuro Neuro

GUDID NEURO02

TeraRecon Neuro allows motion correction and processes, calculates and outputs brain perfusion analysis results for functional, dynamic, and derived imaging datasets acquired with CT or MRI. TeraRecon Neuro results are used for the analysis of dynamic brain perfusion image data, showing properties of changes in contrast over time. This functionality includes calculation of parameters related to brain tissue perfusion, vascular assessment and tissue blood volume.

Terarecon Inc.

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• Primary Device ID: NEURO02
• NIH Device Record Key: 98457127-3f21-4ed2-9112-a0f9fb5ee2fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TeraRecon Neuro
• Version Model Number: Neuro02
• Catalog Number: Neuro
• Company DUNS: 021677872
• Company Name: Terarecon Inc.
• 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: 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
HIBCC	NEURO02 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220349

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-12-04
• Device Publish Date: 2023-06-14

Devices Manufactured by Terarecon Inc.

• NEURO02 - TeraRecon Neuro: 2023-12-04TeraRecon Neuro allows motion correction and processes, calculates and outputs brain perfusion analysis results for functional, dynamic, and derived imaging datasets acquired with CT or MRI. TeraRecon Neuro results are used for the analysis of dynamic brain perfusion image data, showing properties of changes in contrast over time. This functionality includes calculation of parameters related to brain tissue perfusion, vascular assessment and tissue blood volume.
• NEURO02 - TeraRecon Neuro: 2023-12-04 TeraRecon Neuro allows motion correction and processes, calculates and outputs brain perfusion analysis results for functional,
• AQAPS04 - AQAPS: 2021-09-15 AQAPS, also known as AquariusAPS Server, is a stand-alone medical device software which performs various kinds of data processin
• INTUITION04 - Intuition: 2021-09-15 Intuition (also referred to as Aquarius Intuition) is a medical device comprised of two stand-alone software components: a serve