QUANTITATIVE NEUROQ 3.0


Device Classification Name

system, tomography, computed, emission

510(k) Number K072307
Device Name QUANTITATIVE NEUROQ 3.0
Applicant
SYNTERMED, INC.
245 owens dr.
anaheim, 
CA 
92808

Applicant Contact kenneth train
Correspondent
SYNTERMED, INC.
245 owens dr.
anaheim, 
CA 
92808

Correspodent Contact kenneth train
Regulation Number 892.1200
Classification Product Code
KPS  
Date Received 08/17/2007
Decision Date 03/14/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No