Skip to content

Medhot Mti 2000 Thermal Imaging System

by Medhot Thermal Imaging, Inc.

510(k) K063047

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK063047 Date19 Oct 2006ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2057-2017 FDA Class II initiated 14 Jan 2017

    Indications for use are not cleared or approved for market in the U.S.

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  • Withdrawn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
LHQ
Device Class
Class I
Regulation
21 CFR Part 884.2980
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Other devices from Medhot Thermal Imaging, Inc.