DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODEL DVS-I-11: DVS INSERTION TOOL, DVS-D-A: DVS DOSIMETER, DVS-R-100

Device Classification Name

system, radiation therapy, charged-particle, medical

510(k) Number K071399
Device Name DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODEL DVS-I-11: DVS INSERTION TOOL, DVS-D-A: DVS DOSIMETER, DVS-R-100
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
LHN  
Subsequent Product Code
NZT  
Date Received 05/21/2007
Decision Date 06/20/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No