510(k) · Cleared
ClearedLaser Alignment Tool
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems North America, Inc. · IWE Monitor, Patient Position, Light-Beam
Cleared on Aug 9, 1994 as substantially equivalent to K933431 (Trac Medical, Inc., 1993) after a 27-day review. Its family tree reaches back 1 generation to 1993. 1 later device descends from it.
- Decided
- Aug 9, 1994
- Review
- 27 days
- Class
- Class I
- Product code
- IWE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K933431 (1993). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K152303CT Sim Laser SystemGammex, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K933431 | Orthotrac Coaxial Laser | Trac Medical, Inc. | 1993 | — |
| 0 (this device) | K943381 | Laser Alignment Tool | Philips Medical Systems North America, Inc. | 1994 | — |
| +1 | K152303 | CT Sim Laser System | Gammex, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
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
What was it cleared against? (1)
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 | Decided |
|---|---|---|---|
| * | K933431 | Orthotrac Coaxial LaserSummary page 1…d ofinitially aligning it Predicate Device : Orthotrac Coaxial Laser TRAC Medical Systems K933431 - 05 Oct. 1993 Intended Use Statement: The laser alignment tool is used for patient positioning on our BV series M… | 1993 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152303 | CT Sim Laser System | 2015 | 0 |
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?
- Its one ancestor has no recall.
- Of its descendants, K152303 (Gammex, Inc., 2015) has gone furthest, with 0 descendants of its own.
How does its category compare?
All IWE devicesIWE Monitor, Patient Position, Light-Beam: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IWE
1in 2015
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
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IWE
1in 2018
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 laser alignment tool is used for patient positioning on our BV series Mobile Fluoroscopic X-Ray Systems. The current procedure is to use fluoroscopic x-ray exposure to correctly position the patient relative to the central x-ray beam. By providing a visible indicator of the central beam location, patient positioning is facilitated for the surgeon while x-ray dose is reduced for the patient. Clinical applications include situations in which the…
Read the full statement (211 words)
The laser alignment tool is used for patient positioning on our BV series Mobile Fluoroscopic X-Ray Systems. The current procedure is to use fluoroscopic x-ray exposure to correctly position the patient relative to the central x-ray beam. By providing a visible indicator of the central beam location, patient positioning is facilitated for the surgeon while x-ray dose is reduced for the patient. Clinical applications include situations in which the surgeon utilized the x-ray beam for alignment or guidance in a procedure The procedures themselves would not be altered with the exception of the use of the visible spectrum to indicate alignment rather than fluoroscopic shadows. The system consists of a HeNe laser device and an optical guide which allows the light to be emitted long the central axis of the x-ray beam. A means is provided to physically align the beam. The laser alignment tool is an accessory used to visualize the location of the central axis of the x-ray beam whether or not x-rays are energized. It has no clinical value beyond the surgeon's use of that visualization. It does not enable new treatments nor generate information which is not available through other means. The accuracy of the visualization is wholly demonstrable through the use of bench testing and specification.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K943381 · printed Nov 6, 2026
Cite this page
510(k) Report. “K943381: Laser Alignment Tool.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K943381
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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