LUMAGEM MOLECULAR BREAST IMAGING SYSTEM


Device Classification Name

camera, scintillation (gamma)

510(k) Number K111791
Device Name LUMAGEM MOLECULAR BREAST IMAGING SYSTEM
Applicant
GAMMA MEDICA-IDEAS INCORPORATED
755 n. mathilda avenue
suite 100
sunnyvale, 
CA 
94085

Applicant Contact albert boniske
Correspondent
GAMMA MEDICA-IDEAS INCORPORATED
755 n. mathilda avenue
suite 100
sunnyvale, 
CA 
94085

Correspodent Contact albert boniske
Regulation Number 892.1100
Classification Product Code
IYX  
Date Received 06/27/2011
Decision Date 09/23/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No