Cleared Traditional

PROView

K193306 · GE Medical Systems SCS · Radiology

Nov 2020

Decision

354d

Days

Class 2

Risk

About This 510(k) Submission

K193306 is an FDA 510(k) clearance for the PROView, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by GE Medical Systems SCS (Waukesha, US). The FDA issued a Cleared decision on November 17, 2020, 354 days after receiving the submission on November 29, 2019. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K193306 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 29, 2019
Decision Date	November 17, 2020
Days to Decision	354 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF