Cleared Traditional

SEED SELECTRON MODEL V. 1.0

K010032 · Nucletron Corp. · Radiology
Oct 2001
Decision
287d
Days
Class 2
Risk

About This 510(k) Submission

K010032 is an FDA 510(k) clearance for the SEED SELECTRON MODEL V. 1.0, 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 17, 2001, 287 days after receiving the submission on January 3, 2001. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5700.

Submission Details

510(k) Number K010032 FDA.gov
FDA Decision Cleared SESE
Date Received January 03, 2001
Decision Date October 17, 2001
Days to Decision 287 days
Submission Type Traditional
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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