Cleared Traditional

OCENTRA MASTERPLAN 3.1 (OCENTRA BRACHY)

K081281 · Nucletron Corporation · Radiology
May 2008
Decision
14d
Days
Class 2
Risk

About This 510(k) Submission

K081281 is an FDA 510(k) clearance for the OCENTRA MASTERPLAN 3.1 (OCENTRA BRACHY), a System, Planning, Radiation Therapy Treatment (Class II — Special Controls, product code MUJ), submitted by Nucletron Corporation (Columbia, US). The FDA issued a Cleared decision on May 20, 2008, 14 days after receiving the submission on May 6, 2008. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K081281 FDA.gov
FDA Decision Cleared SESE
Date Received May 06, 2008
Decision Date May 20, 2008
Days to Decision 14 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code MUJ — System, Planning, Radiation Therapy Treatment
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.5050