ThermPix

USA THERM, INC. · Model TPix-01 · UDI-DI 00860008801906

510(k) clearances

Adverse events (1 deaths)

Recalls

Facilities

Description

The ThermPix® Thermovisual Camera is intended to view, measure, and record heat patterns and variations. It is intended for use as adjunctive diagnostic imaging for thermally significant indications stemming from heat emitted from the human body. The significance of these thermal patterns and variations is determined by professional investigation. This device is intended for use by qualified technical personnel. Clinical judgement and experience are required to review and interpret the information transmitted. The ThermPix® Thermovisual Camera is only for use in addition to other diagnostic medical devices. It does not provide any absolute measurement of temperature and should not be used for sole screening or diagnosis for any disease or condition. The system is not intended to be used as a thermometry device.

Recalls

Date	Firm	Reason
2017-01-14	Med-Hot Thermal Imaging, Inc.	Indications for use are not cleared or approved for market in the U.S.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.