Cleared Traditional

Insight Essentials DRF Digital Imaging System

K191310 · Imaging Engineering, LLC · Radiology

Jun 2019

Decision

26d

Days

Class 2

Risk

About This 510(k) Submission

K191310 is an FDA 510(k) clearance for the Insight Essentials DRF Digital Imaging System, a System, X-ray, Fluoroscopic, Image-intensified (Class II — Special Controls, product code JAA), submitted by Imaging Engineering, LLC (Cape Coral, US). The FDA issued a Cleared decision on June 10, 2019, 26 days after receiving the submission on May 15, 2019. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number	K191310 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 15, 2019
Decision Date	June 10, 2019
Days to Decision	26 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF