Device Classification Name |
System, Imaging, Pulsed Echo, Ultrasonic
|
510(k) Number |
K213620 |
Device Name |
ATUSA™ Automated 3D Breast Ultrasound System |
Applicant |
iSono Health, Inc. |
395 Oyster Point Blvd., Suite 501 |
South San Fransisco,
CA
94080
|
|
Applicant Contact |
Shadi Saberi |
Correspondent |
Compliance and Regulatory Services LLC |
3771 Southbrook Dr |
Dayton,
OH
45430
|
|
Correspondent Contact |
Daniel Lehtonen |
Regulation Number | 892.1560
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/16/2021 |
Decision Date | 04/22/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|