Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K202056 |
Device Name |
Kinepict Medical Imaging Tool 4.0 |
Applicant |
Kinepict Health Ltd |
Kelta k z |
Budakeszi,
HU
2092
|
|
Applicant Contact |
Lilla Strobel |
Correspondent |
Kinepict Health Ltd |
Kelta k z |
Budakeszi,
HU
2092
|
|
Correspondent Contact |
Lilla Strobel |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 07/24/2020 |
Decision Date | 09/10/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|