Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K193149 |
Device Name |
True 3D Viewer Software |
Applicant |
EchoPixel Inc. |
4677 Old Ironsides Suite 445 |
Santa Clara,
CA
95054
|
|
Applicant Contact |
Michael Gabler |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
Prithul Bom |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 11/13/2019 |
Decision Date | 12/27/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|