Cleared Traditional

K182834 - CS-series-FP with Optional ROI Accessory CA-100S
(FDA 510(k) Clearance)

K182834 · Omega Medical Imaging, LLC · Radiology

Mar 2019

Decision

171d

Days

Class 2

Risk

K182834 is an FDA 510(k) clearance for the CS-series-FP with Optional ROI Accessory CA-100S. This device is classified as a System, X-ray, Fluoroscopic, Image-intensified (Class II — Special Controls, product code JAA).

Submitted by Omega Medical Imaging, LLC (Sanford, US). The FDA issued a Cleared decision on March 29, 2019, 171 days after receiving the submission on October 9, 2018.

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

Submission Details

510(k) Number	K182834 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 09, 2018
Decision Date	March 29, 2019
Days to Decision	171 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF