510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K212965Substantially Equivalent

Smile-100 System

Niramai Health Analytix Private Limited, Bangalore, IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K212965 is the FDA 510(k) clearance record for Smile-100 System, a class I device, cleared for Niramai Health Analytix Private Limited on under FDA product code LHQ (System, Telethermographic (Adjunctive Use)). FDA records list one 510(k) clearance for Niramai Health Analytix Private Limited. As of , FDA records show no recalls naming K212965.

Clearance record

Decision date
Received
(175 days to decision)
Product code
LHQ System, Telethermographic (Adjunctive Use)
Regulation
21 CFR 884.2980
Device class
Class I
Review panel
Obstetrics/Gynecology
Applicant
Niramai Health Analytix Private Limited Innova Pearl, Ground Floor, #17, 5th Block, Koramangala, Bangalore, IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LHQ

Trailing 12 months
1 clearance under product code LHQ in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LHQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260