# K020783: Telesis Digital Infrared Thermal Image System, Spectrum 9000MB

- Pathway: 510(k) (Traditional)
- Applicant: Telesis Technologies, Inc.
- Decided: Jun 7, 2002 after 88 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 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
- K101641: AG Thermographic Camera, Model Atir-M301 (2011), 0 descendants of its own
- K032471: Tytron C-500IR Clinical Infrared Imaging System (2003), 0 descendants of its own

## Indications for use
The device is intended for adjunctive diagnostic screening for detection of breast cancer or other uses.

Source page: https://510kreport.com/device/K020783
Methodology: https://510kreport.com/methodology