MEDHOT MTI 2000 THERMAL IMAGING SYSTEM— 510(k) K063047

Name: FDA 510(k) clearance K063047
Creator: U.S. Food and Drug Administration
Published: 2006-10-19

Substantially Equivalent

Medhot Thermal Imaging, Inc.

FDA 510(k) clearance K063047 for MEDHOT MTI 2000 THERMAL IMAGING SYSTEM, Substantially Equivalent on 2006-10-19. Applicant: Medhot Thermal Imaging, Inc.. Device class: 1.

Clearance details

Applicant: Medhot Thermal Imaging, Inc.
Product code: Code LHQ
Device class: Class 1
Regulation: 21 CFR 884.2980
Advisory panel: Obstetrics/Gynecology
Date received: 2006-10-04
Decision date: 2006-10-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck, NY, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K063047

K-number listed on FDA's recall record

Z-2057-2017 — MEDHOT MTI 2000 THERMAL IMAGING SYSTEM - TotalVision software with Elevated Body Temperature Screening module, for use as a medical diagnostic purposes as part of a telethermographic system utilizing FLIR cameras, Models A615sc and A315sc. Cameras are private labeled as MAX Basic, MAX 76 and MAX 307.Class II·Terminated·Med-Hot Thermal Imaging, Inc.·20170114

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K063047.

Data sourced from openFDA. This site is unofficial and independent of the FDA.