Device Classification Name |
system, image processing, radiological |
|||
---|---|---|---|---|
510(k) Number | K131498 | |||
Device Name | IQQA-LIVER MULTIMODALITY SOFTWARE | |||
Applicant |
|
|||
Applicant Contact | daniel kamm, p.e. | |||
Correspondent |
|
|||
Correspodent Contact | daniel kamm, p.e. | |||
Regulation Number | 892.2050 | |||
Classification Product Code |
|
|||
Date Received | 05/24/2013 | |||
Decision Date | 07/25/2013 | |||
Decision |
substantially equivalent (SESE) |
|||
Regulation Medical Specialty |
Radiology |
|||
510k Review Panel |
Radiology |
|||
summary |
summary |
|||
Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |