Cleared Traditional

CS-SERIES-FP

K100102 · Omega Medical Imaging, Inc. · Radiology

Aug 2010

Decision

230d

Days

Class 2

Risk

About This 510(k) Submission

K100102 is an FDA 510(k) clearance for the CS-SERIES-FP, a Interventional Fluoroscopic X-ray System (Class II — Special Controls, product code OWB), submitted by Omega Medical Imaging, Inc. (Sanford, US). The FDA issued a Cleared decision on August 31, 2010, 230 days after receiving the submission on January 13, 2010. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number	K100102 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 13, 2010
Decision Date	August 31, 2010
Days to Decision	230 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF

Device Classification

Product Code	OWB — Interventional Fluoroscopic X-ray System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 892.1650
Definition	Interventional Fluoroscopy