CT Sim Laser System

FDA 510(k) K152303 · Gammex, Inc.

Substantially Equivalent

510(k) numberK152303

Submission

Device name
CT Sim Laser System
Applicant
Gammex, Inc.
Middleton, WI, US
Received
August 14, 2015
Decision date
September 11, 2015
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
IWE – Monitor, Patient Position, Light-Beam
Device class
Class I (low risk)
Regulation
21 CFR 892.5780
Specialty
Radiology

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K973162Dual Radiation Targeting System DRTS DrapeIWE · Traditional Hogan & Hartson11/20/1997SE
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K954414Centralite BackpointerIWE · Traditional Diacor, Inc.10/23/1995SE
K950293TEC-2110 Green Laser Model Mt-HngIWE · Traditional Medtec, Inc.08/18/1995SE
K950112Centralite(R)-Dll SeriesIWE · Traditional Diacor, Inc.08/16/1995SE
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K943802HP Back Pointer SystemIWE · Traditional Medtec, Inc.12/07/1994SE
K943381Laser Alignment ToolIWE · Traditional Philips Medical Systems North America, Inc.08/09/1994SE
K941169Tec 2101 (Model Mt-Hplgd)IWE · Traditional Medtec, Inc.07/18/1994SE
K935760Tec 2100 (Model Mt-Lplgd)IWE · Traditional Medtec, Inc.01/25/1994SE

More from Medtec, Inc.

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Questions and answers

When was CT Sim Laser System cleared by the FDA?

CT Sim Laser System (K152303) received a 510(k) decision of Substantially Equivalent on September 11, 2015, 28 days after the submission was received.

What is the product code of K152303?

The FDA product code is IWE – Monitor, Patient Position, Light-Beam, a Class I (low risk) device regulated under 21 CFR 892.5780.