Device Classification Name |
Automated Radiological Image Processing Software
|
510(k) Number |
K223501 |
Device Name |
ViewFinder Software Version 1.1 |
Applicant |
Elaitra Ltd |
8B Buckland Crescent, Belsize Park |
London,
GB
NW3 5DX
|
|
Applicant Contact |
Stephen Morrell |
Correspondent |
Elaitra Ltd |
8B Buckland Crescent, Belsize Park |
London,
GB
NW3 5DX
|
|
Correspondent Contact |
Stephen Morrell |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 11/21/2022 |
Decision Date | 04/21/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|