ProFound Detection

GUDID 00850008977541

Icad, Inc.

X-ray image interpretive software

• Primary Device ID: 00850008977541
• NIH Device Record Key: fce80de0-aee2-4e4a-85a8-b323b9c90df8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProFound Detection
• Version Model Number: 4.0
• 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	00850008977541 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240417

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: 2026-03-31
• Device Publish Date: 2026-03-23

Devices Manufactured by Icad, Inc.

• 00850008977541 - ProFound Detection: 2026-03-31
• 00850008977541 - ProFound Detection: 2026-03-31
• 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