Cleared Traditional

ONCENTRA GYN

K080929 · Nucletron Corporation · Radiology
Apr 2008
Decision
15d
Days
Class 2
Risk

About This 510(k) Submission

K080929 is an FDA 510(k) clearance for the ONCENTRA GYN, 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 April 16, 2008, 15 days after receiving the submission on April 1, 2008. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K080929 FDA.gov
FDA Decision Cleared SESE
Date Received April 01, 2008
Decision Date April 16, 2008
Days to Decision 15 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