Cleared Traditional

K210469 - Insight Agile DRF
(FDA 510(k) Clearance)

K210469 · Imaging Engineering, LLC · Radiology

Jul 2021

Decision

161d

Days

Class 2

Risk

K210469 is an FDA 510(k) clearance for the Insight Agile DRF, 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 July 27, 2021, 161 days after receiving the submission on February 16, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number	K210469 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 16, 2021
Decision Date	July 27, 2021
Days to Decision	161 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF