Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K173542 |
Device Name |
Arterys Oncology DL |
Applicant |
Arterys Inc. |
51 Federal Street |
Suite 305 |
san francisco,
CA
94107
|
|
Applicant Contact |
john axerio-cilies |
Correspondent |
Arterys Inc. |
51 Federal Street |
Suite 305 |
san francisco,
CA
94107
|
|
Correspondent Contact |
john axerio-cilies |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 11/16/2017 |
Decision Date | 01/25/2018 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|