Cleared Traditional

R650 QDASM COLLIMATOR

K093572 · Omega Medical Imaging, Inc. · Radiology
Feb 2010
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K093572 is an FDA 510(k) clearance for the R650 QDASM COLLIMATOR, 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 February 3, 2010, 77 days after receiving the submission on November 18, 2009. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1610.

Submission Details

510(k) Number K093572 FDA.gov
FDA Decision Cleared SESE
Date Received November 18, 2009
Decision Date February 03, 2010
Days to Decision 77 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