Cleared Traditional

ONCENTRA BRACHY

K132816 · Nucletron B.V. · Radiology
Jun 2014
Decision
277d
Days
Class 2
Risk

About This 510(k) Submission

K132816 is an FDA 510(k) clearance for the ONCENTRA BRACHY, a System, Planning, Radiation Therapy Treatment (Class II — Special Controls, product code MUJ), submitted by Nucletron B.V. (Rice Lake, US). The FDA issued a Cleared decision on June 13, 2014, 277 days after receiving the submission on September 9, 2013. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K132816 FDA.gov
FDA Decision Cleared SESE
Date Received September 09, 2013
Decision Date June 13, 2014
Days to Decision 277 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