Cleared Special

MICROSELECTRON HDR- GENIE AFTERLOADING SYSTEM, MODEL 105.989 FOR 115VOLT DEVICES AND 105.988 FOR 230VOLT DEVICES

K021286 · Nucletron Corp. · Radiology
May 2002
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K021286 is an FDA 510(k) clearance for the MICROSELECTRON HDR- GENIE AFTERLOADING SYSTEM, MODEL 105.989 FOR 115VOLT DEVICES AND 105.988 FOR 230VOLT DEVICES, 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 May 23, 2002, 30 days after receiving the submission on April 23, 2002. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5700.

Submission Details

510(k) Number K021286 FDA.gov
FDA Decision Cleared SESE
Date Received April 23, 2002
Decision Date May 23, 2002
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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