Cleared Special

INTEGRATED BRACHYTHERAPY UNIT - DIGITAL

K072445 · Nucletron Corp. · Radiology
Sep 2007
Decision
15d
Days
Class 2
Risk

About This 510(k) Submission

K072445 is an FDA 510(k) clearance for the INTEGRATED BRACHYTHERAPY UNIT - DIGITAL, a System, Simulation, Radiation Therapy (Class II — Special Controls, product code KPQ), submitted by Nucletron Corp. (Columbia, US). The FDA issued a Cleared decision on September 14, 2007, 15 days after receiving the submission on August 30, 2007. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5840.

Submission Details

510(k) Number K072445 FDA.gov
FDA Decision Cleared SESE
Date Received August 30, 2007
Decision Date September 14, 2007
Days to Decision 15 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code KPQ — System, Simulation, Radiation Therapy
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.5840

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