ProFound AI 3.1

GUDID 00850008977268

Icad, Inc.

Radiology DICOM image processing application software

• Primary Device ID: 00850008977268
• NIH Device Record Key: ba65d032-a6cd-428c-91c3-facb82a605c4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProFound AI 3.1
• Version Model Number: 3.1
• Company DUNS: 108870254
• Company Name: Icad, 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: true
• Manufacturing Date: true
• 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	00850008977268 [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: 2024-06-18
• Device Publish Date: 2024-06-10

On-Brand Devices [ProFound AI 3.1]

• 00850008977275: 3.1
• 00850008977268: 3.1