FDA Product Code LHQ: System, Telethermographic (adjunctive Use)
Leading manufacturers include Usa Therm, Inc., Neko Health AB and Intouch Technologies, Inc., D.B.A. Intouch Health.
41
Total
41
Cleared
136d
Avg days
1984
Since
Stable submission activity - 1 submissions in the last 2 years
Review times increasing: avg
163d
recently vs 135d historically
FDA 510(k) Cleared System, Telethermographic (adjunctive Use) Devices (Product Code LHQ)
41 devices
Cleared
May 20, 2026
Derma-2
Neko Health AB
Radiology
163d
Cleared
Sep 14, 2023
ThermPix Thermovisual Camera
Usa Therm, Inc.
Radiology
30d
Cleared
Apr 12, 2022
ThermPix Thermovisual Camera
Usa Therm, Inc.
Radiology
144d
Cleared
Mar 10, 2022
Smile-100 System
Niramai Health Analytix Private Limited
Radiology
175d
Cleared
Sep 13, 2021
IRIS-XP
Medicore Co., Ltd.
Radiology
41d
Cleared
Jan 06, 2021
Thermidas IR System (ThIR-A615)
Thermidas Americas, Inc.
Radiology
265d
Cleared
Mar 25, 2019
InTouch Thermal Camera
Intouch Technologies, Inc., D.B.A. Intouch Health
Radiology
270d
About Product Code LHQ - Regulatory Context
510(k) Submission Activity
41 total 510(k) submissions under product code LHQ since 1984, with 41 receiving FDA clearance (average review time: 136 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA 510(k) Review Time - LHQ Product Code
Recent submissions under LHQ have taken an average of 163 days to reach a decision - up from 135 days historically. Manufacturers should account for longer review timelines in current project planning.
LHQ devices are reviewed by the Radiology panel. Browse all Radiology devices →