Cleared Traditional

K152303 - CT Sim Laser System

K152303 is an FDA 510(k) clearance for CT Sim Laser System, manufactured by Gammex, Inc.. The device is a Class 1 Radiology device with product code IWE cleared through the Traditional 510(k) pathway after a 28-day FDA review.

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

K152303 is an FDA 510(k) clearance for the CT Sim Laser System. Classified as Monitor, Patient Position, Light-beam (product code IWE), Class I - General Controls.

Submitted by Gammex, Inc. (Middleton, US). The FDA issued a Cleared decision on September 11, 2015 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5780 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Gammex, Inc. devices

FDA 510(k) Submission Details - K152303

510(k) Number K152303 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 107d · This submission: 28d
Pathway characteristics
Predicate-based equivalence.

IWE Device Classification - Class 1, General Controls

Product Code IWE Monitor, Patient Position, Light-beam
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.5780
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Consultant

Sun Nuclear Corporation
James Luker

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - IWE Monitor, Patient Position, Light-beam

All 11
Devices cleared under the same product code (IWE) and FDA review panel - the closest regulatory comparables to K152303.
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