Device Classification Name |
liver iron concentration imaging companion diagnostic for deferasirox
|
510(k) Number |
K213776 |
Device Name |
LiverSmart |
Applicant |
Resonance Health Analysis Services Pty Ltd |
141 Burswood Road |
Perth,
AU
6100
|
|
Applicant Contact |
Mitchell Wells |
Correspondent |
Resonance Health Analysis Services Pty Ltd |
141 Burswood Road |
Perth,
AU
6100
|
|
Correspondent Contact |
Mitchell Wells |
Regulation Number | 892.1001
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/02/2021 |
Decision Date | 12/29/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|