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 ID00858012005922
NIH Device Record Key6a7f8ee5-14f8-4dc3-b3e5-59d9887e2f71
Commercial Distribution StatusIn Commercial Distribution
Brand NamePowerLook Density Assessment V3.4
Version Model NumberV3.4
Catalog NumberD70141, D70142, D70160
Company DUNS108870254
Company NameIcad, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-866-280-2239
Emailsupport@icadmed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100858012005922 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-08-06
Device Publish Date2018-07-06

Devices Manufactured by Icad, Inc.

00850008977527 - PowerLook 11.32023-08-10
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 1.2.02023-07-24

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.