Device Classification Name |
Automated Radiological Image Processing Software
|
510(k) Number |
K240582 |
Device Name |
VEA Align; spineEOS |
Applicant |
EOS imaging |
10 rue Mercoeur |
Paris,
FR
75011
|
|
Applicant Contact |
Moran Celestin |
Correspondent |
EOS imaging |
10 rue Mercoeur |
Paris,
FR
75011
|
|
Correspondent Contact |
Moran Celestin |
Regulation Number | 892.2050
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/01/2024 |
Decision Date | 06/25/2024 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|