THERATRON 780C/1000 WITH COMPUTERIZED CONSOLE UPGRADE— 510(k) K001006

Name: FDA 510(k) clearance K001006
Creator: U.S. Food and Drug Administration
Published: 2000-04-27

Substantially Equivalent

Mds Nordion

FDA 510(k) clearance K001006 for THERATRON 780C/1000 WITH COMPUTERIZED CONSOLE UPGRADE, Substantially Equivalent on 2000-04-27. Applicant: Mds Nordion. Device class: 2.

Clearance details

Applicant: Mds Nordion
Product code: Code IWB
Device class: Class 2
Regulation: 21 CFR 892.5750
Advisory panel: Radiology
Date received: 2000-03-29
Decision date: 2000-04-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Ottawa, CA

Download summary PDF View on FDA.gov ↗

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