510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K843124Substantially Equivalent

Q-Scan Thermography System

Qmax Medical, Inc., Dayton OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K843124 is the FDA 510(k) clearance record for Q-SCAN THERMOGRAPHY SYSTEM, a class III device, cleared for Qmax Medical, Inc. on under FDA product code KXZ (System, Thermographic, Liquid Crystal, Powered (Adjunctive Use)). FDA records list one 510(k) clearance for Qmax Medical, Inc. As of , FDA records show no recalls naming K843124.

Clearance record

Decision date
Received
(113 days to decision)
Product code
KXZ System, Thermographic, Liquid Crystal, Powered (Adjunctive Use)
Regulation
21 CFR 884.2982
Device class
Class III
Review panel
Obstetrics/Gynecology
Applicant
Qmax Medical, Inc. P.O. Box 1181, Dayton OH
Third party review
No

Clearances, product code KXZ

Trailing 12 months

FDA records hold no clearances under product code KXZ in the trailing twelve months.

FDA records show no clearances under product code KXZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KXZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260