ProFound AI V3.0

GUDID 00850008977176

Icad, Inc.

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• 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.

• 00850008977527 - PowerLook 11.3: 2023-08-10
• 00085000897751 - PowerLook Cloud 1.0: 2023-07-25
• 00850008977442 - PowerLook 11.2: 2023-07-24
• 00850008977459 - PowerLook Al Mammo Container - Radiology Partners v1.0.0: 2023-07-24
• 00850008977466 - PowerLook Al Mammo Container- GE v1.1.0: 2023-07-24
• 00850008977473 - PowerLook Al Mammo Container- Blackford v1.0.0: 2023-07-24
• 00850008977480 - PowerLook Al Mammo Container- Ferrum v1.0.0: 2023-07-24
• 00850008977497 - PowerLook Al Mammo Container - Arterys v 1.2.0: 2023-07-24