# K050239: Emd Thermography System

- Pathway: 510(k) (Traditional)
- Applicant: Em Diagnostics, Inc.
- Decided: Mar 16, 2006 after 407 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 K971956 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003130: Regutherm 952 Thermographic System, Sie-Med, Inc. (2001) Summary page 1.
- K971956: CRT2000 Thermographic System, Werner Eidam Medizin-Technologie GmbH (1997) Summary page 1.

## Indications for use
The EMD Thermography System, Model RTM-02-RES is an infrared spectrum thermography system used to measure, record and view thermal patterns generated by the human body. It is intended for use as an adjunct to other clinical diagnostic procedures in the screening and diagnosis of abnormalities where a physician chooses to use thermography.

Source page: https://510kreport.com/device/K050239
Methodology: https://510kreport.com/methodology