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Q-Scan Thermography System

by Qmax Medical, Inc.

510(k) K843124

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK843124 Date29 Nov 1984ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KXZ
Device Class
Class III
Regulation
21 CFR Part 884.2982
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Q-Scan Thermography System is a Thermographic, Liquid Crystal, Powered System (Adjunctive Use) classified under Obstetrics/Gynecology. It employs liquid crystal technology to capture and display thermal images, aiding in the assessment of physiological temperature variations for diagnostic purposes.

This device is intended for use in clinical settings, supplied as a reusable medical instrument. It operates under FDA 510(k) clearance (K843124) and falls under Device Class III (Regulation Number 884.2982). No specific sterility or single-use designation is noted in the regulatory data, though standard clinical hygiene practices apply. The system is designed for adjunctive use in obstetrics and gynecology evaluations.

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What clinical specialties is the Q-Scan Thermography System primarily used in, and how does it assist in evaluations?

    The Q-Scan Thermography System is designed for adjunctive use in obstetrics and gynecology evaluations. It employs liquid crystal technology to capture thermal images, helping clinicians assess physiological temperature variations that may aid in diagnostic assessments within these specialties.

  • Is the Q-Scan Thermography System intended for single-use or reusable applications, and what hygiene practices should be followed?

    The Q-Scan Thermography System is not designated as single-use and is supplied as a reusable medical instrument. While no specific sterility designation is noted in regulatory data, standard clinical hygiene practices—such as cleaning and disinfection between uses—should be followed to maintain safety and functionality.

  • How was the Q-Scan Thermography System evaluated for regulatory clearance, and what committee reviewed it?

    The Q-Scan Thermography System underwent a traditional 510(k) review process and was classified under Obstetrics/Gynecology by the Obstetrics (OB) Advisory Committee. It was determined to be substantially equivalent to a predicate device, with clearance granted under K-number K843124 on November 29, 1984.

  • What type of technology does the Q-Scan Thermography System use, and how does it function in a clinical setting?

    The Q-Scan Thermography System utilizes thermographic and liquid crystal technology to capture and display thermal images. In clinical settings, it aids in visualizing physiological temperature variations, serving as an adjunctive tool for diagnostic evaluations in obstetrics and gynecology.