Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K170172 |
Device Name |
UNiD Spine Analyzer |
Applicant |
MEDICREA INTERNATIONAL |
5389 Route de Strasbourg-Vancia |
Rillieux La Pape,
FR
69140
|
|
Applicant Contact |
David Ryan |
Correspondent |
Hogan Lovells US LLP |
5389 Route de Strasbourg - Vancia |
Rillieux La Pape,
FR
|
|
Correspondent Contact |
David Ryan |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 01/19/2017 |
Decision Date | 05/24/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|