# K101641: AG Thermographic Camera, Model Atir-M301

- Pathway: 510(k) (Traditional)
- Applicant: Ag Digital Technology Corp.
- Decided: Jun 16, 2011 after 371 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: 3 generations back to K951806 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033967: Telethermographic Camera, Series a, E, S and P, Flir Systems (2004) Summary page 1.
- K020783: Telesis Digital Infrared Thermal Image System, Spectrum 9000MB, Telesis Technologies, Inc. (2002) Summary page 1.

## Indications for use
The AG Thermographic Camera(Model no.: ATIR M301) is intended to use as an adjunct to other clinical diagnostic procedures by quantifying differences in skin surface temperature changes. It can visualize and digitalize body surface temperature distribution and temperature changes. The device is intended for use by qualified healthcare personnel trained in its use.

Source page: https://510kreport.com/device/K101641
Methodology: https://510kreport.com/methodology