PowerLook Density Assessment V4.0

GUDID 00850008977251

Icad, Inc.

Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software

• Primary Device ID: 00850008977251
• NIH Device Record Key: f0f99853-192f-44e3-af75-730b3fd36fd9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PowerLook Density Assessment V4.0
• Version Model Number: 4.0
• 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	00850008977251 [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

Devices Manufactured by Icad, Inc.

• 00850008977053 - TESTING: 2024-06-18
• 00850008977251 - PowerLook Density Assessment V4.0: 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