LHQ · Class I · 21 CFR 884.2980

FDA Product Code LHQ: System, Telethermographic (adjunctive Use)

Leading manufacturers include Usa Therm, Inc., Thermidas Americas, Inc. and Medicore Co., Ltd..

40
Total
40
Cleared
135d
Avg days
1984
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared System, Telethermographic (adjunctive Use) Devices (Product Code LHQ)

40 devices
1–24 of 40
Cleared Sep 14, 2023
ThermPix Thermovisual Camera
K232462
Usa Therm, Inc.
Radiology · 30d
Cleared Apr 12, 2022
ThermPix Thermovisual Camera
K213650
Usa Therm, Inc.
Radiology · 144d
Cleared Mar 10, 2022
Smile-100 System
K212965
Niramai Health Analytix Private Limited
Radiology · 175d
Cleared Sep 13, 2021
IRIS-XP
K212412
Medicore Co., Ltd.
Radiology · 41d
Cleared Jan 06, 2021
Thermidas IR System (ThIR-A615)
K200999
Thermidas Americas, Inc.
Radiology · 265d

About Product Code LHQ - Regulatory Context

510(k) Submission Activity

40 total 510(k) submissions under product code LHQ since 1984, with 40 receiving FDA clearance (average review time: 135 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

LHQ devices are reviewed by the Radiology panel. Browse all Radiology devices →