Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K120115 |
Device Name |
ORTHOSIZE |
Applicant |
ORTHOSIZE LLC |
1835 MARKET STREET, 29TH FLOOR |
PHILADELPHIA,
PA
19103
|
|
Applicant Contact |
YARMELA PAVLOVIC |
Correspondent |
ORTHOSIZE LLC |
1835 MARKET STREET, 29TH FLOOR |
PHILADELPHIA,
PA
19103
|
|
Correspondent Contact |
YARMELA PAVLOVIC |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 01/13/2012 |
Decision Date | 03/14/2012 |
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
|
|
|