Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K173444 |
Device Name |
Quantitative Total Extensible Imaging (QTxI) |
Applicant |
AIQ Solutions, Inc. |
8025 Excelsior Drive |
madison,
WI
53717
|
|
Applicant Contact |
dona alberti |
Correspondent |
EpiReg LLC |
3428 John Muir Drive |
middleton,
WI
53562
|
|
Correspondent Contact |
mitch lewandowski |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 11/06/2017 |
Decision Date | 07/23/2018 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|