# K073581: Ici P and S Series IR Cameras

- Pathway: 510(k) (Traditional)
- Applicant: Texas Infrared
- Decided: Jul 11, 2008 after 204 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: 3 generations back to K951806 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033967: Telethermographic Camera, Series a, E, S and P, Flir Systems (2004) Summary page 1.

## Indications for use
The ICI Series P and S IR Cameras, which provides capture of skin surface temperature of any part of the body, and the IR Flash Software version 1.0, which provides visualization and reporting functionalities, are intended for use as an adjunct to other clinical diagnostic procedures in the diagnosis, quantifying, and screening of relative skin surface temperature. Environment of use: hospitals, sub-acute healthcare settings, public areas, i.e., airports.

Source page: https://510kreport.com/device/K073581
Methodology: https://510kreport.com/methodology