DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM


Device Classification Name

dosimeter, ionizing radiation, implanted

510(k) Number K080004
Device Name DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM
Applicant
SICEL TECHNOLOGIES, INC.
3800 gateway centre blvd.
suite 308
morrisville, 
NC 
27560

Applicant Contact tammy b carrea
Correspondent
SICEL TECHNOLOGIES, INC.
3800 gateway centre blvd.
suite 308
morrisville, 
NC 
27560

Correspodent Contact tammy b carrea
Regulation Number 892.5050
Classification Product Code
NZT  
Date Received 01/02/2008
Decision Date 01/23/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No