FDA-Device2017-05-17Class II
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.
Hazard
Indications for use are not cleared or approved for market in the U.S.
Sold states
US: AL and NJ - Foreign: Nigeria
Affected count
12
Manufactured in
5120 S Florida Ave Ste 301, N/A, Lakeland, FL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2057-2017Don't want to check this manually?
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