Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Usa Therm, Inc.. It received FDA 510(k) clearance on 2023-09-14 under approval 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. It is manufactured by Usa Therm, Inc.. The 510(k) number is K232462.

When was ThermPix Thermovisual Camera approved by the FDA?

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

What company makes ThermPix Thermovisual Camera?

ThermPix Thermovisual Camera is manufactured by Usa Therm, Inc..

What is the FDA product code for ThermPix Thermovisual Camera?

The FDA product code for ThermPix Thermovisual Camera is LHQ.

Other Devices by Usa Therm, Inc.

K213650ThermPix Thermovisual Camera

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 K181716InTouch Thermal CameraIntouch Technologies, Inc., D.B.A. Intouch Health K212412IRIS-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.

↑