# K063047: Medhot Mti 2000 Thermal Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Medhot Thermal Imaging, Inc.
- Decided: Oct 19, 2006 after 15 days
- Product code: LHQ (System, Telethermographic (Adjunctive Use))
- Device class: 1
- Regulation: 21 CFR 884.2980
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Telethermographic camera Series A, E, P, and S: named in the summary without a submission number

## Most influential descendants
- K171928: Med-Hot Thermal Imaging Systems (2017), 6 descendants of its own
- K181716: InTouch Thermal Camera (2019), 2 descendants of its own
- K213650: ThermPix Thermovisual Camera (2022), 1 descendant of its own
- K200999: Thermidas IR System (ThIR-A615) (2021), 1 descendant of its own
- K253911: Derma-2 (2026), 0 descendants of its own

## Recalls of this device
- Jan 14, 2017 · Class II · Z-2057-2017: Indications for use are not cleared or approved for market in the U.S.

## Indications for use
Intended for qualified healthcare personnel who are trained in its use, the MedHot MTI 2000 is a non-contact, non-invasive, non-radiating, thermographic imaging device for use as an adjunct to other clinical diagnostic procedures in the capture, quantification, and screening, of differences in skin surface temperature changes. The device can digitally render quantitative images of thermal data via the capture and algorithmic interpretation of relative infrared information from the imaging camera in collaborative use with a compatible computer system which provides a user interface and image storage. Patient populations and environmental use includes all age groups from adult to pediatric and neonatal in hospital, sub acute and public areas i.e. airports.

Source page: https://510kreport.com/device/K063047
Methodology: https://510kreport.com/methodology