WRDensity by Whiterabbit AI

GUDID 00860005853601

Software application that uses machine learning to assess breast tissue composition.

Ai Whiterabbit Inc

Radiology DICOM image processing application software

• Primary Device ID: 00860005853601
• NIH Device Record Key: 809c917a-6f58-4523-ae02-68bf8cd71d79
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WRDensity by Whiterabbit AI
• Version Model Number: WRDensity-1
• Company DUNS: 117017441
• Company Name: Ai Whiterabbit 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860005853601 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202013

FDA Product Code

• QIH: Automated Radiological Image Processing Software

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: 2021-01-12
• Device Publish Date: 2021-01-04