FLEXIPLAN BRACHYTHERAPY TREATMENT PLANNING SYSTEM


Device Classification Name

system,planning,radiation therapy treatment

510(k) Number K081112
Device Name FLEXIPLAN BRACHYTHERAPY TREATMENT PLANNING SYSTEM
Applicant
ISODOSE CONTROL B.V.
landjuweel 11
veenendaal, 

NL

3905 pe

Applicant Contact hub van de bergh
Correspondent
ISODOSE CONTROL B.V.
landjuweel 11
veenendaal, 

NL

3905 pe

Correspodent Contact hub van de bergh
Regulation Number 892.5050
Classification Product Code
MUJ  
Date Received 04/18/2008
Decision Date 07/29/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No