510(k) · Cleared

Cleared

Smile-100 System

K212965510(k) TraditionalCleared Mar 10, 2022175-day reviewClass I21 CFR 884.2980

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Niramai Health Analytix Private Limited · LHQ System, Telethermographic (Adjunctive Use)

Cleared on Mar 10, 2022 as substantially equivalent to K171928 (Med-Hot Thermal Imaging, Inc., 2017) after a 175-day review. Its family tree reaches back 2 generations to 2006.

Decided: Mar 10, 2022
Review: 175 days
Class: Class I
Product code: LHQ
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K063047 (2006). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK063047 Medhot Mti 2000 Thermal Imaging SystemMedhot Thermal Imaging, Inc. · 2006 · Recalled
1 generation backK171928 Med-Hot Thermal Imaging SystemsMed-Hot Thermal Imaging, Inc. · 2017
This deviceK212965 Smile-100 SystemNiramai Health Analytix Private Limited · 2022

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K063047	Medhot Mti 2000 Thermal Imaging System	Medhot Thermal Imaging, Inc.	2006	1
−1	K171928	Med-Hot Thermal Imaging Systems	Med-Hot Thermal Imaging, Inc.	2017	—
0 (this device)	K212965	Smile-100 System	Niramai Health Analytix Private Limited	2022	—

FIG. 1 — Lineage of K212965, 2006–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LHQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LHQ device

#1 K253911 Derma-2score 12.0 · 3 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K171928	Med-Hot Thermal Imaging Systems Summary page 4 …Med-Hot Thermal Imaging Systems Manufacturer Med-Hot Thermal Imaging, Inc. 510(k) Number K171928 SMILE-100 System 510(k) NIRAMAI Confidential 5.4 Device Desc…	Med-Hot Thermal Imaging, Inc.	2017	—
†	K033967	Telethermographic Camera, Series a, E, S and P	Flir Systems	2004	—
†	K032471	Tytron C-500IR Clinical Infrared Imaging System	Titronics Research & Development Co.	2003	—
†	K073581	Ici P and S Series IR Cameras	Texas Infrared	2008	—

Also cleared against K171928: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 11.1 years on median.
1 of the 2 ancestors has a recall of any class.
2 other devices also cite its predicate K171928.

How does its category compare?

All LHQ devices

LHQ System, Telethermographic (Adjunctive Use): FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.

FDA decisions per year · LHQ

1in 2023

2007high 2 (2017) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LHQ

Too few LHQ 510(k)s in any year since 2007 to give a median.

Recalls per year · LHQ

No recall names LHQ since 2007.

Adverse event reports per year · LHQ

1in 2025

2007high 2 (2019) · low 0 (2007)2025

MAUDE reports naming product code LHQ, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	1	—	0
2009	0	—	0
2010	0	—	0
2011	1	—	0
2012	1	—	0
2013	0	—	1
2014	0	—	0
2015	1	—	0
2016	1	—	0
2017	2	—	0
2018	0	—	0
2019	1	—	2
2020	0	—	1
2021	2	—	1
2022	2	—	0
2023	1	—	0
2024	0	—	0
2025	0	—	1
2026	1	—	—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K212965 · printed Nov 6, 2026

Cite this page

510(k) Report. “K212965: Smile-100 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212965

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026