ProFound AI V3.0

GUDID 00850008977176

Icad, Inc.

Basic diagnostic x-ray system application software

• Primary Device ID: 00850008977176
• NIH Device Record Key: fb43b2f7-f81f-4965-b0dd-7f330ab9c08d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProFound AI V3.0
• Version Model Number: 3.0
• Company DUNS: 108870254
• Company Name: Icad, 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: 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	00850008977176 [Primary]

FDA Product Code

• QDQ: Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer

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: 2021-05-25
• Device Publish Date: 2021-05-17

Devices Manufactured by Icad, Inc.

• 00850008977053 - TESTING: 2024-06-18
• 00850008977251 - PowerLook Density Assessment V4.0: 2024-06-18
• 00850008977268 - ProFound AI 3.1: 2024-06-18
• 00850008977275 - ProFound AI 3.1: 2024-06-18
• 00850008977282 - TESTING: 2024-06-18
• 00850008977299 - PowerLook PRO+ 4GPU Tower Platform, OUS: 2024-06-18
• 00850008977305 - PowerLook 10.1.1: 2024-06-18
• 00850008977312 - PowerLook MammoAI Container - Sectra: 2024-06-18