Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K211443 |
Device Name |
AIBOLIT 3D+ |
Applicant |
AIbolit Technologies, LLC |
9616 Moritz Way |
Delray Beach,
FL
33446
|
|
Applicant Contact |
Howard Schrayer |
Correspondent |
AIbolit Technologies, LLC |
9616 Moritz Way |
Delray Beach,
FL
33446
|
|
Correspondent Contact |
Howard Schrayer |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 05/10/2021 |
Decision Date | 01/07/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|