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Certification

What is FDA 510(k) and does this product meet the requirements?
Seek Scan is not 510(k) cleared or intended to replace a medical thermometer. However, based on FDA guidelines published April 2020, the FDA states that it accepts the use of thermal cameras for initial body temperature assessment for triage use without a 510(k) clearance during the health emergency, provided the thermal imaging system meets the standards set forth in the guidance. Seek Scan meets all of these applicable standards including the accuracy specification, inclusion of a reference heat source and is made for single person screening.  

 

Is Seek Scan a medical device?
The FDA issued guidelines in April 2020 for the use of thermal imaging for elevated body temperature screening during the COVID-19 public health emergency. The guidance takes the position that in this case thermal imaging devices are intended for medical purposes and/or medical use and therefore it is deemed a medical device.

 

Is this product medically approved?
Based on FDA guidelines published April 2020, the FDA states that it accepts the use of thermal cameras for initial body temperature assessment for triage use without a 510(k) clearance during the COVID-19 public health emergency, provided the thermal imaging system meets the standards set forth in the guidance. Seek Scan meets all of these applicable standards. Seek is planning to get FDA 510(k) clearance in the future when the public health emergency is finished. We currently do not have a planned date for this and will monitor the emergency status with the FDA and HHS.

 

Does this meet NDAA compliance?
Yes, Seek Scan is NDAA compliant.

 

Does this have CE and UL certification?
Yes. Seek Scan has CE and UL certification.

 

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