Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K130395 |
Device Name |
STEREOS WORKSTATION |
Applicant |
EOS IMAGING INC. |
555 THIRTEENTH ST, NW |
WASHINGTON,
DC
20004
|
|
Applicant Contact |
JOHN J SMITH |
Correspondent |
EOS IMAGING INC. |
555 THIRTEENTH ST, NW |
WASHINGTON,
DC
20004
|
|
Correspondent Contact |
JOHN J SMITH |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 02/15/2013 |
Decision Date | 03/11/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|