Device product
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.
Z-2057-2017
Product summary
- Event
- Event 76622
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12
- Official record key
device-enforcement:Z-2057-2017
Official wording
Reason: Indications for use are not cleared or approved for market in the U.S.
Code information: P/N 18001-EBT-MP-D with FLIR A315 camera P/N 15102-EBT-MP-D wjth FLIR A615 camera TotalVision Software versions 1.6 1.7.1
Distribution pattern: US: AL and NJ - Foreign: Nigeria
Derived failure modes
-
Unknown
Indications for use are not cleared or approved for market in the U.S.