Cleared Special

K200396 - Insight Enhanced DRF Digital Imaging System (FDA 510(k) Clearance)

K200396 · Imaging Engineering, LLC · Radiology device

Mar 2020

Decision

17d

Days

Class 2

Risk

K200396 is an FDA 510(k) clearance for the Insight Enhanced 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 March 6, 2020, 17 days after receiving the submission on February 18, 2020.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number	K200396 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 18, 2020
Decision Date	March 06, 2020
Days to Decision	17 days
Submission Type	Special
Review Panel	Radiology (RA)
Summary	Summary PDF