# K102554: Avita Scaneo IR Thermometer Model TS4X Series

- Pathway: 510(k) (Special)
- Applicant: Avita Corporation
- Decided: Mar 3, 2011 after 177 days
- Product code: FLL (Continuous Measurement Thermometer)
- Device class: 2
- Regulation: 21 CFR 880.2910
- 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
The device is an infrared thermometer intended for the intermittent measurement of human body temperature in people of all ages.

Source page: https://510kreport.com/device/K102554
Methodology: https://510kreport.com/methodology