Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K033825 |
Device Name |
ORTHOPACS |
Applicant |
ETRAUMA.COM CORP. |
7 TIFFANY TRAIL |
HOPKINTON,
MA
01748
|
|
Applicant Contact |
DEBBIE IAMPIETRO |
Correspondent |
ETRAUMA.COM CORP. |
7 TIFFANY TRAIL |
HOPKINTON,
MA
01748
|
|
Correspondent Contact |
DEBBIE IAMPIETRO |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 12/10/2003 |
Decision Date | 02/02/2004 |
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
|
|
|