Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K172346 |
Device Name |
sterEOS Workstation |
Applicant |
EOS imaging |
10 rue Mercoeur |
Paris,
FR
75011
|
|
Applicant Contact |
Mathias Breuil |
Correspondent |
EOS imaging |
10 rue Mercoeur |
Paris,
FR
75011
|
|
Correspondent Contact |
Mathias Breuil |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 08/03/2017 |
Decision Date | 06/19/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|