Dahua USA Admits Thermal Solutions "Qualify As Medical Devices"

By John Honovich and Charles Rollet, Published Jul 02, 2020, 07:32am EDT (Info+)

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'.

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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 *******:

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***** **** ******** **** **** * 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:

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

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

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***** ***** *** ****** ** ********* 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)

Undisclosed #1

07/02/20 12:06pm

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

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Agree: 3
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Funny: 1

Undisclosed #2

IPVMU Certified | In reply to Undisclosed #1 | 08/02/20 05:02pm

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

Agree
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Funny: 1

Undisclosed Manufacturer #3

In reply to Undisclosed #2 | 08/02/20 06:40pm

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

Agree
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Funny

Juan Sebastian Charneca

07/02/20 02:51pm

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

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

******.

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Avatar

Jeremiah Main

IPVMU Certified | 07/30/20 06:57pm

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

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John Honovich

IPVM | In reply to Jeremiah Main | 08/01/20 02:26pm

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

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

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

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