Cleared Special

MICROSELECTRON HDR V2, MODEL 105.999

K092804 · Nucletron Corp. · Radiology
Oct 2009
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K092804 is an FDA 510(k) clearance for the MICROSELECTRON HDR V2, MODEL 105.999, 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 October 8, 2009, 27 days after receiving the submission on September 11, 2009. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5700.

Submission Details

510(k) Number K092804 FDA.gov
FDA Decision Cleared SESE
Date Received September 11, 2009
Decision Date October 08, 2009
Days to Decision 27 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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