Device Classification Name |
Automated Radiological Image Processing Software
|
510(k) Number |
K210791 |
Device Name |
Us2.v1 |
Applicant |
eko.ai Pte. Ltd. d/b/a Us2.ai |
2 College Road, #02-00 |
Singapore,
SG
94080
|
|
Applicant Contact |
James Hare |
Correspondent |
Enzyme Corporation |
611 Gateway Blvd Ste 120 |
South San Francisco,
CA
94080
|
|
Correspondent Contact |
Jared Seehafer |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 03/16/2021 |
Decision Date | 07/27/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|