510(k) K232462

ThermPix Thermovisual Camera by Usa Therm, Inc. — Product Code LHQ

K232462 is an FDA 510(k) premarket notification submitted by Usa Therm, Inc. for the device "ThermPix Thermovisual Camera". The FDA issued a decision of Substantially Equivalent on September 14, 2023. The device falls under product code LHQ (System, Telethermographic (Adjunctive Use)), a Class I device regulated under 21 CFR 884.2980. Usa Therm, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 2023
Date Received
August 15, 2023
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Telethermographic (Adjunctive Use)
Device Class
Class I
Regulation Number
884.2980
Review Panel
RA
Submission Type