| Device Classification Name |
Radiological Computer-Assisted Triage And Notification Software
|
| 510(k) Number |
K192167 |
| Device Name |
CuraRad-ICH |
| Applicant |
| Curacloud Corp. |
| 999 Third Ave., Suite 700 |
|
Seattle,
WA
98104
|
|
| Applicant Contact |
Xiaoxiao Liu |
| Correspondent |
| Manatt, Phelps, & Phillips, Llp |
| One Embarcadero Center, 30th Floor |
|
San Francisco,
CA
94111
|
|
| Correspondent Contact |
Yarmela Pavlovic |
| Regulation Number | 892.2080 |
| Classification Product Code |
|
| Date Received | 08/09/2019 |
| Decision Date | 04/13/2020 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Radiology
|
| 510k Review Panel |
Radiology
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|