THERATRON EQUINOX, MODELS 80 CM AND 100 CM— 510(k) K053485

Name: FDA 510(k) clearance K053485
Creator: U.S. Food and Drug Administration
Published: 2006-03-09

Substantially Equivalent

Mds Nordion, Inc.

FDA 510(k) clearance K053485 for THERATRON EQUINOX, MODELS 80 CM AND 100 CM, Substantially Equivalent on 2006-03-09. Applicant: Mds Nordion, Inc.. Device class: 2.

Clearance details

Applicant: Mds Nordion, Inc.
Product code: Code IWB
Device class: Class 2
Regulation: 21 CFR 892.5750
Advisory panel: Radiology
Date received: 2005-12-15
Decision date: 2006-03-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Ottawa, CA

Download summary PDF View on FDA.gov ↗

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