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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 the device name listed in this FDA 510(k) record. The listed applicant is Intouch Technologies, Inc., D.B.A. Intouch Health. It received FDA 510(k) clearance on 2019-03-25 under 510(k) 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. The listed applicant is Intouch Technologies, Inc., D.B.A. Intouch Health. The 510(k) number is K181716.

When did InTouch Thermal Camera receive FDA 510(k) clearance?

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

Who is the listed applicant for InTouch Thermal Camera?

The FDA 510(k) record lists Intouch Technologies, Inc., D.B.A. Intouch Health as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for InTouch Thermal Camera?

The FDA product code for InTouch Thermal Camera is LHQ.

Related Devices (Code: LHQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253911Derma-2Neko Health ABK232462ThermPix Thermovisual CameraUsa Therm, Inc.K213650ThermPix Thermovisual CameraUsa Therm, Inc.K212965Smile-100 SystemNiramai Health Analytix Private LimitedK212412IRIS-XPMedicore Co., Ltd.K200999Thermidas IR System (ThIR-A615)Thermidas Americas, 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.

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