ONCENTRA PROSTATE 4.0— 510(k) K112420

Substantially Equivalent

Nucletron

FDA 510(k) clearance K112420 for ONCENTRA PROSTATE 4.0, Substantially Equivalent on 2011-11-18. Applicant: Nucletron. Device class: 2.

Clearance details

Applicant: Nucletron
Product code: Code JAQ
Device class: Class 2
Regulation: 21 CFR 892.5700
Advisory panel: Radiology
Date received: 2011-08-23
Decision date: 2011-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

Download summary PDF View on FDA.gov ↗

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More clearances from Nucletron

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