DISCOVERY NM 630


Device Classification Name

system, tomography, computed, emission

510(k) Number K111445
Device Name DISCOVERY NM 630
Applicant
GE HEALTHCARE
4 hayozma street
tirat hacarmel, 

IL

30200

Applicant Contact tal bresler-stramer
Regulation Number 892.1200
Classification Product Code
KPS  
Date Received 05/24/2011
Decision Date 06/03/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No

Recalls CDRH Recalls