THERATRON 780C/1000 WITH COMPUTERIZED CONSOLE UPGRADE


codes

Device Classification Name

system, radiation therapy, radionuclide

510(k) Number K001006
Device Name THERATRON 780C/1000 WITH COMPUTERIZED CONSOLE UPGRADE
Original Applicant
MDS NORDION
447 march rd.
ottawa, ontario, 

CA

k2k1x8

Original Contact e s martell
Regulation Number 892.5750
Classification Product Code
IWB  
Date Received 03/29/2000
Decision Date 04/27/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls