MULTI-SPECT


Device Classification Name

system, tomography, computed, emission

510(k) Number K073021
Device Name MULTI-SPECT
Applicant
EAGLE HEART IMAGING, LLC
8407 bryant st.
westminster, 
CO 
80031 -3809

Applicant Contact john koss
Regulation Number 892.1200
Classification Product Code
KPS  
Date Received 10/26/2007
Decision Date 11/06/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No