Dahua USA Admits Thermal Solutions "Qualify As Medical Devices"

Avatar
JH
Charles Rollet and John Honovich
•Published Jul 02, 2020 11:32 AM

Dahua USA has issued a press release admitting a controversial point in the industry but an obvious one to the US FDA, that the thermal temperature screening systems they are selling indeed 'qualify as medical devices'.

IPVM Image

Inside this note, we examine why this is good for the public and for the buyers of these systems but challenges Dahua's sales efforts, runs counter to Dahua's global marketing, and increases the pressure on Hikvision USA who continues to refuse to admit the obvious.

Medical *******

** **** *, ****, *************:

***** ******* ********* *** **, *** commonly ***, **** ** *** ********* for ********** ********** *********, *** ** such,qualify ** “******* *******” as set out in the FDA guidance. [emphasis added]

** ********, ******* **** ****, **** issued * ***** *******% ** ** ******* ********* * of *****'* ************ **** **** ***** ******** **** not ******* *******.

**** ********* * ************** *** ***** USA **** *** **** * ******, in ***** *** ******* ***** ******* by ************ ********* **** **** *** medical *******:

IPVM Image

***** **** ******** **** **** * cryptic, "*** ***** ******* ********* *** not ***-******* ** ********" ***** ***** true *** *** ******* *** ******* that ***** ***** ******** *** ******* devices ******* ** *** **********.

***, ***** *** *** ************ **** explicitly:

***** ** ********* ********* *** ******* its ******* ********* ** *** ****** States ******* ***(*) ********* **reliance **** *** *** ********. [emphasis added]

Following *** ********, *******

*****'* ****** ************** **** **** *** following *** ******** ** ********* ******* even **** *** ********* *** ******** not ** ****** ** ****** ***(*) clearance, *** *** ***** *** ***********, labeling, ********** ********* ************** ***** ** ******* ** ***** products. ** **********, ******* ********* ** almost *** ******** ** *** ***** markets ***** ******** ****** *** *****.

** *** ***** ** *** ******** Dahua *** ****** ******* *** ***'* 510(k) ***********, ******* ********* ***** ******* for ***** ****** *** *** ********* in ***** ****** ***** *********** *** ******** **** *********. **** ****** ***** USA **** * *********** ***** ****-***** on *** ********.

Dahua ************* *********

***** *** *** ************* ******* *** aggressiveness ** *** ********* ******** ** its ********* ******. *** *******, ***********, ** ****************** ** ***** ********* ********* **** month ******** * ********** *********** ******** that **** ******* ***** *** ************ instructions:

IPVM Image

*** **** *********,***** ** ********* ** ******************** *** ********** ******** ** ***** temperature ********* ** * ****** ** an *********:

IPVM Image

*** ** ***, ***** ****************-*********** ***** ******* *** * ****** nursing ****,*********** *** *******:

IPVM Image

***** ***** *** ****** ** ********* for ****** ***** ** ******* *** reality ** ***** ********* *** ********* the ******* '******* ******' ******, ***** and ** ********* *** ***** ******** by ****** *****'* ********* ************* *********.

Hikvision *********

***** ********* *** ** ******** *** most ********* ****** (***** *** ** *** ***'* "********* Chinese ******** *******" ****), ********* *** ********* ** ******* market *** ******** ** *** ***** medical *******. ********* ************ ****'* ******* for ******* ** *****'* **** **** but ******** ** *******.

*** **** **** *** ********* *** is **** *** **** * *********** (if ******** *******) ********* **** ***** USA, ** **** ***** *** ** now ******** ********* ***** ******* ** be ******* ******* ***** ********* ** not. **** ***** ********* *** ******** to **** ******* ****** *** ********. Plus, ********* ******** **** ********* * blackbody ***** ********, ***** ***** ****** FDA ********** (***** ********* **** ******* a *.*°* ********),**** ******* ** ********* ******* * blackbody****** ************* ********* ********.

Outlook ********* *** ** *********** ********* ******

*** **** *********** **** ******* *** in *** **** ****** ***** ******, the ****** ** ** *** ******. While *** ****** ***** ****** **** the ********* *** ***** ************ **** various *******, **** *****, **** *********** over *** **** *** ******, *** trend ** *********.

Comments (6)
U
Undisclosed #1
•Jul 02, 2020

** ********* **** *** ******, *** they *** ******* *******, *** *** system ***** ***** ***** *********** **** sub *-****** *********. ** *** ****** in *** ******! *>

IPVM Image

(3)
(1)
U
Undisclosed #2
•Aug 02, 2020
IPVMU Certified
In reply to Undisclosed #1

*** ***** *** ** ******* * fever, *** ***** ****** ***...IPVM Image

(1)
UM
Undisclosed Manufacturer #3
•Aug 02, 2020
In reply to Undisclosed #2

***** ***** *** ********** ** **** detection.

JS
Juan Sebastian Charneca
•Jul 02, 2020

*****,****** ******** ********** ****: "

******** *********' ** ******* ******** *********** Detection ********"

******.

Avatar
Jeremiah Main
•Jul 30, 2020
IPVMU Certified

***** *** *** **** *** ********* that **** ******* *** ***(*) ************? I ***** **** **** *** ******** products ** *** *** *******. *'* like ** ******* **** ********* *** say **** **** ******* ******** **** - **** **** **** *** ******.

JH
John Honovich
•Aug 01, 2020
IPVM
In reply to Jeremiah Main

********* **** **** ******* *** ***(*) certfication?...*'* **** ** ******* **** ********* who *** **** **** ******* ******** have - **** **** **** *** others.

***** ********* **** *** **** ******** *******, **** **** **** ****** ** apply, *.*., "***** ******* ** ****** applications *** ***(*) *********".

*** *** ****** **************** ************ & ****** ********** ** **** **** **** ********* have **********, ***** ** ** ********* of ********* ********* ** ***** *** just ******* * ******* ** *** listed ***** *** **** *** **** they **** *** *****.