510(k) · Cleared

Cleared

CT Sim Laser System

K152303510(k) TraditionalCleared Sep 11, 201528-day reviewClass I21 CFR 892.5780

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Gammex, Inc. · IWE Monitor, Patient Position, Light-Beam

Cleared on Sep 11, 2015 as substantially equivalent to K943381 (Philips Medical Systems North America, Inc., 1994) and 1 other predicate after a 28-day review. Its family tree reaches back 2 generations to 1993.

Decided: Sep 11, 2015
Review: 28 days
Class: Class I
Product code: IWE
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K933431 (1993). 3 ancestors in all, the oldest K872489 (1987). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK933431 Orthotrac Coaxial LaserTrac Medical, Inc. · 1993
1 generation backK943381 Laser Alignment ToolPhilips Medical Systems North America, Inc. · 1994
This deviceK152303 CT Sim Laser SystemGammex, Inc. · 2015

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K933431	Orthotrac Coaxial Laser	Trac Medical, Inc.	1993	—
−1	K943381	Laser Alignment Tool	Philips Medical Systems North America, Inc.	1994	—
0 (this device)	K152303	CT Sim Laser System	Gammex, Inc.	2015	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1987	1	0

FIG. 1 — Lineage of K152303, 1993–2015Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in IWE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) Report

What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K943381	Laser Alignment Tool Summary page 5 …5 === Predicate Device(s): Model Name: Philips Laser Alignment Tool Common Name: Laser alignment system 510(k) # K943381 Manufacturer: Philips Medical Systems Submitted: July 13, 1994 Model Name: Cen…	Philips Medical Systems North America, Inc.	1994	—
*	K872489	Centralite Summary page 5 …tems Submitted: July 13, 1994 Model Name: Centralite Common Name: Laser alignment system 510(k) # K872489 Manufacturer: Diacor Inc. Submitted: June 23, 1987 To our knowledge, these predica…	Diacor, Inc.	1987	—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 21.1 years on median.
None of the 3 ancestors has a recall.

How does its category compare?

All IWE devices

IWE Monitor, Patient Position, Light-Beam: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · IWE

1in 2015

2007high 1 (2015) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IWE

Too few IWE 510(k)s in any year since 2007 to give a median.

Recalls per year · IWE

1in 2025

2007high 2 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · IWE

1in 2018

2007high 1 (2009) · low 0 (2007)2025

MAUDE reports naming product code IWE, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	0	0
2008	0	—	0	0
2009	0	—	1	1
2010	0	—	0	0
2011	0	—	2	0
2012	0	—	0	0
2013	0	—	0	0
2014	0	—	0	0
2015	1	—	0	1
2016	0	—	0	0
2017	0	—	0	0
2018	0	—	0	1
2019	0	—	0	0
2020	0	—	0	0
2021	0	—	0	0
2022	0	—	0	0
2023	0	—	2	0
2024	0	—	0	0
2025	0	—	1	0
2026	0	—	0	—

What is it indicated for?

The CT Sim Laser System is used in the simulation stage of radiation therapy to prepare a patient for treatment. The lasers can be moved to a point that defines the isocenter in the CT suite. The Gammex CT Sim is intended to read laser positioning coordinates in a Gammex specified software format from a file in a shared folder. Typically the coordinates were calculated by a Radiation Therapy Treatment Planning System (RTPS) using CT images and sent to the Hospital Information System (HIS), Oncology System (OIS) or other system, by the RTPS.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K152303 · printed Nov 6, 2026

Cite this page

510(k) Report. “K152303: CT Sim Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152303

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026