Eureka

GUDID B2208430011

Eureka AI Results Explorer (aka Northstar AI Results Explorer and Northstar) is a zero-footprint, web-based software device indicated for use in clinical settings where medical images and image-derived metadata can be accessed or visualized to aid healthcare professionals in diagnosis and patient management decision making. Eureka AI Results Explorer’s web interfaces can obtain and consume both DICOM and non-DICOM image-derived metadata generated by Artificial Intelligence (AI) or computer vision algorithms.

TERARECON, INC.

Radiology DICOM image processing application software

• Primary Device ID: B2208430011
• NIH Device Record Key: 211e716d-be36-435e-86b4-5d6ef0512d5d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eureka
• Version Model Number: Eureka AI Results Explorer
• Company DUNS: 116929750
• Company Name: TERARECON, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	B2208430011 [Primary]

FDA Product Code

• LMD: System, Digital Image Communications, 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: 2020-12-02
• Device Publish Date: 2020-11-24

On-Brand Devices [Eureka]

• B220843002A8430031: An application software program designed to function as a portal to allow software providers to
• B2208430011: Eureka AI Results Explorer (aka Northstar AI Results Explorer and Northstar) is a zero-footprint