PowerLook Density Assessment V3.4 D70141, D70142, D70160

GUDID 00858012005922

"PowerLook Density Assessment 3.4 is a software application intended for use with DBT 2D images from tomosynthesis exams. PowerLook Density Assessment 3.4 provides a BI-RADS 5th Edition breast density category to aid health care professionals in the assessment of breast tissue composition. PowerLook Density Assessment 3.4 produces adjunctive information. It is not a diagnostic aid.  

Icad, Inc.

Basic diagnostic x-ray system application software

• Primary Device ID: 00858012005922
• NIH Device Record Key: 6a7f8ee5-14f8-4dc3-b3e5-59d9887e2f71
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PowerLook Density Assessment V3.4
• Version Model Number: V3.4
• Catalog Number: D70141, D70142, D70160
• 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: false
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: 1-866-280-2239
• Email: support@icadmed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858012005922 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180125

FDA Product Code

• LLZ: System, Image Processing, 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: 2018-08-06
• Device Publish Date: 2018-07-06

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