Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K151687 |
Device Name |
QuantorView |
Applicant |
3DISC AMERICAS |
22560 GLENN DR STE 116 |
STERLING,
VA
20164
|
|
Applicant Contact |
SIGRID SMITT-JEPPESEN |
Correspondent |
KAMM & ASSOCIATES |
8870 RAVELLO CT |
NAPLES,
FL
34114
|
|
Correspondent Contact |
DANIEL KAMM |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 06/23/2015 |
Decision Date | 08/03/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|