Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K213140 |
Device Name |
Claritas iPET |
Applicant |
Claritas HealthTech Pte Ltd |
20A Tanjong Pagar Road |
Singapore,
SG
088443
|
|
Applicant Contact |
Devika Dutt |
Correspondent |
Claritas HealthTech Pte Ltd |
20A Tanjong Pagar Road |
Singapore,
SG
088443
|
|
Correspondent Contact |
Devika Dutt |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 09/27/2021 |
Decision Date | 12/22/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|