510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Med-Hot Thermal Imaging, Inc.

Lakeland, FL, US

MED-HOT THERMAL IMAGING, INC appears in FDA device records in Lakeland, FL. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
1
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 1 510(k) clearance for Med-Hot Thermal Imaging, Inc. in 2017.

Clearances by year, as a table
510(k) clearance decisions for Med-Hot Thermal Imaging, Inc., by decision year
YearClearances
20171
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K171928Med-Hot Thermal Imaging SystemsLHQSubstantially Equivalent

Registered establishments

FDA registered establishments for Med-Hot Thermal Imaging, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30060332133006033213MED-HOT THERMAL IMAGING, INC2502 Ewell Road, Lakeland, FL 33811 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2057-2017MEDHOT 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.Indications for use are not cleared or approved for market in the U.S.Class IITerminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain