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FDA 510(k)

ThermPix Thermovisual Camera

K-Number: K232462 · 2023-09-14

ApplicantUsa Therm, Inc.
Decision Date2023-09-14
Product CodeLHQ
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ThermPix Thermovisual Camera is the device name listed in this FDA 510(k) record. The listed applicant is Usa Therm, Inc.. It received FDA 510(k) clearance on 2023-09-14 under 510(k) number K232462. 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 ThermPix Thermovisual Camera?

ThermPix Thermovisual Camera is a medical device that received FDA 510(k) clearance on 2023-09-14. The listed applicant is Usa Therm, Inc.. The 510(k) number is K232462.

When did ThermPix Thermovisual Camera receive FDA 510(k) clearance?

ThermPix Thermovisual Camera received FDA 510(k) clearance on 2023-09-14, under 510(k) number K232462.

Who is the listed applicant for ThermPix Thermovisual Camera?

The FDA 510(k) record lists Usa Therm, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ThermPix Thermovisual Camera?

The FDA product code for ThermPix Thermovisual Camera is LHQ.

Other records listing Usa Therm, Inc. as applicant

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.

K213650ThermPix Thermovisual Camera

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 ABK213650ThermPix Thermovisual CameraUsa Therm, Inc.K212965Smile-100 SystemNiramai Health Analytix Private LimitedK212412IRIS-XPMedicore Co., Ltd.K200999Thermidas IR System (ThIR-A615)Thermidas Americas, Inc.K181716InTouch Thermal CameraIntouch Technologies, Inc., D.B.A. Intouch Health

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.

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