# K023925: Mark I Thermal Imager

- Pathway: 510(k) (Traditional)
- Applicant: Ix-Dr, Inc.
- Decided: Feb 11, 2003 after 78 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Thennal Imaging is a medical imaging modality for use: as an adjuxlctive procedwe to supporc other diagmstic modalities. For example, thermal imaging of breasts c8n demonstrate a temperatute variance as a method to help cluuify findings indicated by mammography or some other duqpostic procedure. Thermal. imaging in general is a determination of physiologic rather than anatomic change. Neoangioenesis accompanies tumor growth and typically produces an deration in blood vessels. Aay changes in blood vessel activity generally introduce a change in temperature in the immediaie area ofthe affected blood vessel. Thermography is incapable of visualizing anatomic matter unless it is accompanied by an atternion in surface temperature. Hence, thermography is an adjunctive medical imaging modality.

Source page: https://510kreport.com/device/K023925
Methodology: https://510kreport.com/methodology