510(k) K063047 ยท LHQ System, Telethermographic (Adjunctive Use)
MEDHOT MTI 2000 THERMAL IMAGING SYSTEM
| Applicant | Medhot Thermal Imaging, Inc., Great Neck NY, US |
| Decision | Substantially Equivalent, Oct 19, 2006 |
| Received | Oct 4, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063047
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 14, 2017 | Med-Hot Thermal Imaging, Inc. 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 Terminated |
LHQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.