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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K190694
Device Name Unifi Workspace v1.0.0
Applicant
Hologic, Inc.
36 Apple Ridge Rd.
Danbury,  CT  06810
Applicant Contact Meghan Wakeford
Correspondent
Hologic, Inc.
36 Apple Ridge Rd.
Danbury,  CT  06810
Correspondent Contact Meghan Wakeford
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received03/18/2019
Decision Date 07/11/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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