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510(k) K011246

DCM 1.0 by Mds Nordion — Product Code MUJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 2001
Date Received
April 23, 2001
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Planning, Radiation Therapy Treatment
Device Class
Class II
Regulation Number
892.5050
Review Panel
RA
Submission Type

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  • K001006 — THERATRON 780C/1000 WITH COMPUTERIZED CONSOLE UPGRADE (April 27, 2000)

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