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FDA 510(k)

ATS Thermal Imaging Probe, ATS Patient Interface Unit

K-Number: K180148 · 2018-03-21

ApplicantSecurus Medical Group, Inc.
Decision Date2018-03-21
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ATS Thermal Imaging Probe, ATS Patient Interface Unit is a medical device manufactured by Securus Medical Group, Inc.. It received FDA 510(k) clearance on 2018-03-21 under approval number K180148. 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 ATS Thermal Imaging Probe, ATS Patient Interface Unit?

ATS Thermal Imaging Probe, ATS Patient Interface Unit is a medical device that received FDA 510(k) clearance on 2018-03-21. It is manufactured by Securus Medical Group, Inc.. The 510(k) number is K180148.

When was ATS Thermal Imaging Probe, ATS Patient Interface Unit approved by the FDA?

ATS Thermal Imaging Probe, ATS Patient Interface Unit received FDA 510(k) clearance on 2018-03-21, under approval number K180148.

What company makes ATS Thermal Imaging Probe, ATS Patient Interface Unit?

ATS Thermal Imaging Probe, ATS Patient Interface Unit is manufactured by Securus Medical Group, Inc..

What is the FDA product code for ATS Thermal Imaging Probe, ATS Patient Interface Unit?

The FDA product code for ATS Thermal Imaging Probe, ATS Patient Interface Unit is FLL.

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Related PubMed Literature

PMID: 41987469 [Progress and Prospects of Ultrasound Brain-Computer Interface Medical Devices Technology]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2026) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

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Official Source

View on FDA Database →

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

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