# K200999: Thermidas IR System (ThIR-A615)

- Pathway: 510(k) (Traditional)
- Applicant: Thermidas Americas, Inc.
- Decided: Jan 6, 2021 after 265 days
- Product code: LHQ (System, Telethermographic (Adjunctive Use))
- Device class: 1
- Regulation: 21 CFR 884.2980
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K063047 (2006). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171928: Med-Hot Thermal Imaging Systems, Med-Hot Thermal Imaging, Inc. (2017) Summary page 4.

## Most influential descendants
- K253911: Derma-2 (2026), 0 descendants of its own

## Indications for use
The Thermidas IR System is for adjunctive use in addition to other clinical diagnostic procedures for diagnostic imaging for thermally significant indications of all skin regions of the human body. The system is for reviewing and reporting of temperature patterns and changes. The significance of the value of these thermal patterns is determined by professional investigation. The system is not intended for absolute temperature measurements. The Thermidas IR system is intended for use by trained technical personnel.

Source page: https://510kreport.com/device/K200999
Methodology: https://510kreport.com/methodology