Device Classification Name |
system, imaging, pulsed echo, ultrasonic
|
510(k) Number |
K201597 |
Device Name |
Liver Incytes, Model 1005 |
Applicant |
Sonic Incytes |
560-828 West 10th Ave |
Vancouver,
CA
v5z 1m9
|
|
Applicant Contact |
George Aliphtiras |
Correspondent |
Z & B Enterprises, Inc. |
12154 Darnestown Road, #236 |
Gaithersburg,
MD
20878
|
|
Correspondent Contact |
Rhona Shanker |
Regulation Number | 892.1560
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/12/2020 |
Decision Date | 07/31/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|