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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name automated radiological image processing software
510(k) Number K211506
Device Name PowerLook Density Assessment V4.0
iCAD, Inc.
98 Spit Brook Rd Suite 100
Nashua,  NH  03062
Applicant Contact Heather Reed
iCAD, Inc.
98 Spit Brook Rd. Suite 100
Nashua,  NH  03062
Correspondent Contact Heather Reed
Regulation Number892.2050
Classification Product Code
Date Received05/14/2021
Decision Date 07/12/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No