# K023434: Dorex Spectrum 9000MB Thermography System

- Pathway: 510(k) (Special)
- Applicant: Dorex, Inc.
- Decided: Nov 14, 2002 after 30 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.
3 later devices descend 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K033967: Telethermographic Camera, Series a, E, S and P (2004), 2 descendants of its own
- K101641: AG Thermographic Camera, Model Atir-M301 (2011), 0 descendants of its own
- K073581: Ici P and S Series IR Cameras (2008), 0 descendants of its own

## Indications for use
Thermal Imaging is a noninvasive diagnostic technique that allows a practitioner to quantify and visualize skin surface temperature changes. The Spectrum 9000 ME3 allows the user to graphically map the body temperature and display the image on a monitor The Spectrum 9000MB will be used as an aid for diagnosis as well as to follow up therapy on such areas as orthopedics, pain management, neurology and diabetic foot care. The intended use for the Spectrum 9000 MB is similar to what is being used currently on the Dorex DTI- 16 thermal imager. Images are captured and stored on a computer that can be used to diagnose problem areas.

Source page: https://510kreport.com/device/K023434
Methodology: https://510kreport.com/methodology