Cleared Traditional

K191310 - Insight Essentials DRF Digital Imaging System (FDA 510(k) Clearance)

K191310 · Imaging Engineering, LLC · Radiology device

Jun 2019

Decision

26d

Days

Class 2

Risk

K191310 is an FDA 510(k) clearance for the Insight Essentials DRF Digital Imaging System. This device is classified as 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 FDA review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number	K191310 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (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