Cleared Traditional

ONCENTRA RT VIEWER 1.0

K082642 · Nucletron Corporation · Radiology
Nov 2008
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K082642 is an FDA 510(k) clearance for the ONCENTRA RT VIEWER 1.0, 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 November 7, 2008, 57 days after receiving the submission on September 11, 2008. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K082642 FDA.gov
FDA Decision Cleared SESE
Date Received September 11, 2008
Decision Date November 07, 2008
Days to Decision 57 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