MOLECULAR BREAST IMAGING SOFTWARE


Device Classification Name

system, image processing, radiological

510(k) Number K111731
Device Name MOLECULAR BREAST IMAGING SOFTWARE
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 892.2050
Classification Product Code
LLZ  
Date Received 06/20/2011
Decision Date 09/15/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No