Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K180125 |
Device Name |
PowerLook Density Assessment Software |
Applicant |
iCAD, Inc |
98 Spitbrook Road |
Suite 100 |
Nashua,
NH
03062
|
|
Applicant Contact |
John DeLucia |
Correspondent |
iCAD, Inc |
98 Spitbrook Road |
Suite 100 |
Nashua,
NH
03062
|
|
Correspondent Contact |
John DeLucia |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 01/16/2018 |
Decision Date | 04/05/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|