Cleared Traditional

Unifi Workspace v1.0.0

K190694 · Hologic, Inc. · Radiology
Jul 2019
Decision
115d
Days
Class 2
Risk

About This 510(k) Submission

K190694 is an FDA 510(k) clearance for the Unifi Workspace v1.0.0, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Hologic, Inc. (Danbury, US). The FDA issued a Cleared decision on July 11, 2019, 115 days after receiving the submission on March 18, 2019. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K190694 FDA.gov
FDA Decision Cleared SESE
Date Received March 18, 2019
Decision Date July 11, 2019
Days to Decision 115 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LLZ — System, Image Processing, Radiological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050