FDA 510(k)

InTouch Thermal Camera

K-Number: K181716 · 2019-03-25

ApplicantIntouch Technologies, Inc., D.B.A. Intouch Health

Decision Date2019-03-25

Product CodeLHQ

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

InTouch Thermal Camera is a medical device manufactured by Intouch Technologies, Inc., D.B.A. Intouch Health. It received FDA 510(k) clearance on 2019-03-25 under approval number K181716. The device is classified under product code LHQ. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the InTouch Thermal Camera?

InTouch Thermal Camera is a medical device that received FDA 510(k) clearance on 2019-03-25. It is manufactured by Intouch Technologies, Inc., D.B.A. Intouch Health. The 510(k) number is K181716.

When was InTouch Thermal Camera approved by the FDA?

InTouch Thermal Camera received FDA 510(k) clearance on 2019-03-25, under approval number K181716.

What company makes InTouch Thermal Camera?

InTouch Thermal Camera is manufactured by Intouch Technologies, Inc., D.B.A. Intouch Health.

What is the FDA product code for InTouch Thermal Camera?

The FDA product code for InTouch Thermal Camera is LHQ.

Related Clinical Trials

NCT06472622 Functional Neuroimaging to Detect the Neural Signatures of the Unpleasantness of Pain and Effort RECRUITING NCT07524062 The Application of Infrared Thermography in the Prediction of Skin Healing in Surgery NOT_YET_RECRUITING

Related Devices (Code: LHQ)

K160573FirstSense Breast ExamFirst Sense Medical, LLC K171928Med-Hot Thermal Imaging SystemsMed-Hot Thermal Imaging, Inc. K162767Sentinel BreastScan II SystemFirst Sense Medical, LLC K212412IRIS-XPMedicore Co., Ltd. K200999Thermidas IR System (ThIR-A615)Thermidas Americas, Inc. K213650ThermPix Thermovisual CameraUsa Therm, Inc.

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.