CT CoPilot

GUDID 00860000004800

CT CoPilot is intended for use in automating post-acquisition quantitative analysis of CT images of the brain for patients aged 18 or older. CT CoPilot performs automatic reformatting, labeling and quantification of segmentable structures from a set of CT images of the brain. Output of the software provides these values as numerical volumes and images which have been annotated with graphical color overlays, with each color representing a specific brain structure. When CT imaging is performed more than once on a patient, the current data is co-registered to the most recently processed prior exam of the same patient, facilitating comparison between the studies using CT CoPilot. Voxel-by-voxel subtraction maps of the pixel density change in Hounsfield Units (HU) are generated in up to 3 dimensions between the current and most recent processed prior exam of the patient.

MULTIMODAL IMAGING SERVICES CORPORATION

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• Primary Device ID: 00860000004800
• NIH Device Record Key: 9d435556-fe94-4ddb-9ce3-c74b7a04d54e
• Commercial Distribution Discontinuation: 2050-11-27
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CT CoPilot
• Version Model Number: 1.5
• Company DUNS: 080983193
• Company Name: MULTIMODAL IMAGING SERVICES CORPORATION
• 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
GS1	00860000004800 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161322

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: 3
• Public Version Date: 2019-11-21
• Device Publish Date: 2018-11-27

Devices Manufactured by MULTIMODAL IMAGING SERVICES CORPORATION

• 00860000004817 - RSI-MRI+: 2019-12-09 RSI-MRI+ is standalone software that is used by radiologists, urologists, and other clinicians to assist with analysis and inter
• 00860000004800 - CT CoPilot: 2019-11-21CT CoPilot is intended for use in automating post-acquisition quantitative analysis of CT images of the brain for patients aged 18 or older. CT CoPilot performs automatic reformatting, labeling and quantification of segmentable structures from a set of CT images of the brain. Output of the software provides these values as numerical volumes and images which have been annotated with graphical color overlays, with each color representing a specific brain structure. When CT imaging is performed more than once on a patient, the current data is co-registered to the most recently processed prior exam of the same patient, facilitating comparison between the studies using CT CoPilot. Voxel-by-voxel subtraction maps of the pixel density change in Hounsfield Units (HU) are generated in up to 3 dimensions between the current and most recent processed prior exam of the patient.
• 00860000004800 - CT CoPilot: 2019-11-21 CT CoPilot is intended for use in automating post-acquisition quantitative analysis of CT images of the brain for patients aged