# K032471: Tytron C-500IR Clinical Infrared Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Titronics Research & Development Co.
- Decided: Oct 10, 2003 after 60 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: 1 generation back to K020783 (2002). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020783: Telesis Digital Infrared Thermal Image System, Spectrum 9000MB, Telesis Technologies, Inc. (2002)

## Indications for use
The TyTron C-500iR Clinical infrared Imaging System is intended for adjunctive hagnostic screening for the detection of breast cancer and other uses such as: peripheral vascular disease. neuromusculoskeletal disorders, extracranial cerebral and facial vascular chsease, thyroid gland abnornihties, and vaiious other neoplasfc, metabolic, and inflammatory conditions. Use of the TyTron C-SOOIR System is not. intended to be the sole dlapostic procedure for these hseases and conht,ions.

Source page: https://510kreport.com/device/K032471
Methodology: https://510kreport.com/methodology