Cleared Traditional

R605 FACS COLLIMETER

K050092 · Omega Medical Imaging, Inc. · Radiology
Jan 2005
Decision
17d
Days
Class 2
Risk

About This 510(k) Submission

K050092 is an FDA 510(k) clearance for the R605 FACS COLLIMETER, a Collimator, Automatic, Radiographic (Class II — Special Controls, product code IZW), submitted by Omega Medical Imaging, Inc. (Sanford, US). The FDA issued a Cleared decision on January 31, 2005, 17 days after receiving the submission on January 14, 2005. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1610.

Submission Details

510(k) Number K050092 FDA.gov
FDA Decision Cleared SESE
Date Received January 14, 2005
Decision Date January 31, 2005
Days to Decision 17 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IZW — Collimator, Automatic, Radiographic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1610