Eureka

GUDID B220843002A8430031

An application software program designed to function as a portal to allow software providers to make available radiological interpretive software [typically artificial intelligence (AI) based] for radiology professionals to access, use, evaluate, and compare. It is intended to facilitate distribution and hospital implementation of algorithms designed to assist image interpretation within a healthcare facility.

TERARECON, INC.

Radiological image interpretive software sharing portal Radiological image interpretive software sharing portal Radiological image interpretive software sharing portal Radiological image interpretive software sharing portal Radiological image interpretive software sharing portal Radiological image interpretive software sharing portal Radiological image interpretive software sharing portal Radiological image interpretive software sharing portal Radiological image interpretive software sharing portal Radiological image interpretive software sharing portal Radiological image interpretive software sharing portal Radiological image interpretive software sharing portal Radiological image interpretive software sharing portal Radiological image interpretive software sharing portal Radiological image interpretive software sharing portal Radiological image interpretive software sharing portal Radiological image interpretive software sharing portal Radiological image interpretive software sharing portal Radiological image interpretive software sharing portal Radiological image interpretive software sharing portal Radiological image interpretive software sharing portal Radiological image interpretive software sharing portal Radiological image interpretive software sharing portal Radiological image interpretive software sharing portal Radiological image interpretive software sharing portal Radiological image interpretive software sharing portal Radiological image interpretive software sharing portal Radiological image interpretive software sharing portal Radiological image interpretive software sharing portal

• Primary Device ID: B220843002A8430031
• NIH Device Record Key: ec083e3e-ee6c-4500-b657-e0351c7dc595
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eureka
• Version Model Number: Eureka AI Interoperability Platform
• 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	B220843002A8430031 [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