Cleared Traditional

CT Sim Laser System

K152303 · Gammex, Inc. · Radiology
Sep 2015
Decision
28d
Days
Class 1
Risk

About This 510(k) Submission

K152303 is an FDA 510(k) clearance for the CT Sim Laser System, a Monitor, Patient Position, Light-beam (Class I — General Controls, product code IWE), submitted by Gammex, Inc. (Middleton, US). The FDA issued a Cleared decision on September 11, 2015, 28 days after receiving the submission on August 14, 2015. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5780.

Submission Details

510(k) Number K152303 FDA.gov
FDA Decision Cleared SESE
Date Received August 14, 2015
Decision Date September 11, 2015
Days to Decision 28 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IWE — Monitor, Patient Position, Light-beam
Device Class Class I — General Controls
CFR Regulation 21 CFR 892.5780