GUIDEMIA


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
Regulation Number 892.2050
Classification Product Code
LLZ  
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