FDA 510(k)

IRTS Thermal Imaging Probe (TIP);IRTS Patient Monitoring Unit (PMU);IRTS Patient Interface Unit (PIU)

K-Number: K152402 · 2016-03-04

Decision Date2016-03-04

Product CodeFLL

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

IRTS Thermal Imaging Probe (TIP);IRTS Patient Monitoring Unit (PMU);IRTS Patient Interface Unit (PIU) is a medical device manufactured by Securus,Inc. It received FDA 510(k) clearance on 2016-03-04 under approval number K152402. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IRTS Thermal Imaging Probe (TIP);IRTS Patient Monitoring Unit (PMU);IRTS Patient Interface Unit (PIU)?

IRTS Thermal Imaging Probe (TIP);IRTS Patient Monitoring Unit (PMU);IRTS Patient Interface Unit (PIU) is a medical device that received FDA 510(k) clearance on 2016-03-04. It is manufactured by Securus,Inc. The 510(k) number is K152402.

When was IRTS Thermal Imaging Probe (TIP);IRTS Patient Monitoring Unit (PMU);IRTS Patient Interface Unit (PIU) approved by the FDA?

IRTS Thermal Imaging Probe (TIP);IRTS Patient Monitoring Unit (PMU);IRTS Patient Interface Unit (PIU) received FDA 510(k) clearance on 2016-03-04, under approval number K152402.

What company makes IRTS Thermal Imaging Probe (TIP);IRTS Patient Monitoring Unit (PMU);IRTS Patient Interface Unit (PIU)?

IRTS Thermal Imaging Probe (TIP);IRTS Patient Monitoring Unit (PMU);IRTS Patient Interface Unit (PIU) is manufactured by Securus,Inc.

What is the FDA product code for IRTS Thermal Imaging Probe (TIP);IRTS Patient Monitoring Unit (PMU);IRTS Patient Interface Unit (PIU)?

The FDA product code for IRTS Thermal Imaging Probe (TIP);IRTS Patient Monitoring Unit (PMU);IRTS Patient Interface Unit (PIU) is FLL.

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Related PubMed Literature

PMID: 41938148 Device failures and patient adverse events from EUS: 26-year FDA MAUDE analysis (2000-2025). Endoscopic ultrasound (2026) PMID: 41694722 Lessons from global materiovigilance systems: What India can learn? Perspectives in clinical research (2026) PMID: 41533265 Modernizing Medical Software Regulation in Bangladesh: A Roadmap for Risk-Based SaMD Oversight. Journal of medical systems (2026) PMID: 41105489 Medical device shelf-life and recalls: navigating healthcare challenges. Expert review of medical devices (2025)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.