Cleared Traditional

PLATO BRACHYTHERAPHY, MODEL V. 14.0

K983343 · Nucletron Corp. · Radiology
Apr 1999
Decision
191d
Days
Class 2
Risk

About This 510(k) Submission

K983343 is an FDA 510(k) clearance for the PLATO BRACHYTHERAPHY, MODEL V. 14.0, a System, Planning, Radiation Therapy Treatment (Class II — Special Controls, product code MUJ), submitted by Nucletron Corp. (Columbia, US). The FDA issued a Cleared decision on April 2, 1999, 191 days after receiving the submission on September 23, 1998. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K983343 FDA.gov
FDA Decision Cleared SESE
Date Received September 23, 1998
Decision Date April 02, 1999
Days to Decision 191 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