ONCENTRA MANUAL LOW DOSE RATE TREATMENT PLANNING— 510(k) K113102

Name: FDA 510(k) clearance K113102
Creator: U.S. Food and Drug Administration
Published: 2011-12-12

Substantially Equivalent

Nucletron

FDA 510(k) clearance K113102 for ONCENTRA MANUAL LOW DOSE RATE TREATMENT PLANNING, Substantially Equivalent on 2011-12-12. Applicant: Nucletron. Device class: 2.

Clearance details

Applicant: Nucletron
Product code: Code MUJ
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 2011-10-19
Decision date: 2011-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.