Data / Medical devices / United States / Med-Hot Thermal Imaging, Inc
Med-Hot Thermal Imaging, Inc: FDA-registered device maker in Lakeland, FL, United States, 1 510(k) clearance
Med-Hot Thermal Imaging, Inc is registered with the FDA (registration 3006033213) in Lakeland, FL, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated December 8, 2017. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3006033213
- Address
- 2502 Ewell Road, Lakeland, FL, United States, 33811
- Owner or operator
- MED-HOT THERMAL IMAGING, INC (9094861)
- Roles
- Manufacturer
- First device listed
- December 12, 2017
- Registered through
- 2026
- Brand names listed
- Max 76 and Max 307
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Telethermographic (Adjunctive Use) | LHQ | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 8, 2017 | K171928 | Med-Hot Thermal Imaging Systems | LHQ | Substantially Equivalent | Med-Hot Thermal Imaging, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| January 14, 2017 | 76622 | Class II | Terminated | 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 | Indications for use are not cleared or approved for market in the U.S. | accessdata.fda.gov |
Compare with other makers
Updated December 8, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.