Cleared Special

MICROSELECTRON V3, MODEL 106.990

K061354 · Nucletron Corporation · Radiology
Aug 2006
Decision
94d
Days
Class 2
Risk

About This 510(k) Submission

K061354 is an FDA 510(k) clearance for the MICROSELECTRON V3, MODEL 106.990, a System, Applicator, Radionuclide, Remote-controlled (Class II — Special Controls, product code JAQ), submitted by Nucletron Corporation (Columbia, US). The FDA issued a Cleared decision on August 17, 2006, 94 days after receiving the submission on May 15, 2006. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5700.

Submission Details

510(k) Number K061354 FDA.gov
FDA Decision Cleared SESE
Date Received May 15, 2006
Decision Date August 17, 2006
Days to Decision 94 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code JAQ — System, Applicator, Radionuclide, Remote-controlled
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.5700

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