# K212965: Smile-100 System

- Pathway: 510(k) (Traditional)
- Applicant: Niramai Health Analytix Private Limited
- Decided: Mar 10, 2022 after 175 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: 2 generations back to K063047 (2006). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171928: Med-Hot Thermal Imaging Systems, Med-Hot Thermal Imaging, Inc. (2017) Summary page 4.

## Indications for use
SMILE-100 System is intended to review, measure and record skin temperature patterns and variations emitted from the human body. It is intended for use as adjunctive diagnostic imaging for thermally significant indications in the breast region. The significance of the value of these thermal patterns is determined by professional investigation. This device is intended for use by qualified healthcare personnel trained in its use. The system is not intended for absolute temperature measurements. The system is not intended to be used as a thermometry device.

Source page: https://510kreport.com/device/K212965
Methodology: https://510kreport.com/methodology