510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K861534Substantially Equivalent for Some Indications

Model 450 Infrared Imaging System

Mitek, Inc., Marquette MI / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K861534 is the FDA 510(k) clearance record for MODEL 450 INFRARED IMAGING SYSTEM, a class I device, cleared for Mitek , Inc. on under FDA product code LHQ (System, Telethermographic (Adjunctive Use)). FDA records list one 510(k) clearance for Mitek , Inc. As of , FDA records show no recalls naming K861534.

Clearance record

Decision date
Received
(85 days to decision)
Product code
LHQ System, Telethermographic (Adjunctive Use)
Regulation
21 CFR 884.2980
Device class
Class I
Review panel
Obstetrics/Gynecology
Applicant
Mitek , Inc. 2572 Us Hwy. 41 W., Marquette MI
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