510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K023925Substantially Equivalent

Mark I Thermal Imager

Ix-Dr, Inc., Howell MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K023925 is the FDA 510(k) clearance record for MARK I THERMAL IMAGER, a class I device, cleared for Ix-Dr, Inc. on under FDA product code LHQ (System, Telethermographic (Adjunctive Use)). FDA records list one 510(k) clearance for Ix-Dr, Inc. As of , FDA records show no recalls naming K023925.

Clearance record

Decision date
Received
(78 days to decision)
Product code
LHQ System, Telethermographic (Adjunctive Use)
Regulation
21 CFR 884.2980
Device class
Class I
Review panel
Obstetrics/Gynecology
Applicant
Ix-Dr, Inc. 120 State, Howell MI
510(k) summary
Statement
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