Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K121466 |
Device Name |
GUIDEMIA |
Applicant |
GUIDEMIA TECHNOLOGIES, LLC |
4841 ASHBURY AVE. |
CYPRESS,
CA
90630
|
|
Applicant Contact |
FEI GAO |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
MARK JOB |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 05/17/2012 |
Decision Date | 05/31/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|