Cleared Special

MICROSELECTRON PDR

K041933 · Nucletron Corp. · Radiology
Aug 2004
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K041933 is an FDA 510(k) clearance for the MICROSELECTRON PDR, a System, Applicator, Radionuclide, Remote-controlled (Class II — Special Controls, product code JAQ), submitted by Nucletron Corp. (Columbia, US). The FDA issued a Cleared decision on August 18, 2004, 30 days after receiving the submission on July 19, 2004. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5700.

Submission Details

510(k) Number K041933 FDA.gov
FDA Decision Cleared SESE
Date Received July 19, 2004
Decision Date August 18, 2004
Days to Decision 30 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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