Cleared Special

SWIFT 2.0, MODEL 132.001

K031158 · Nucletron Corp. · Radiology
Aug 2003
Decision
118d
Days
Class 2
Risk

About This 510(k) Submission

K031158 is an FDA 510(k) clearance for the SWIFT 2.0, MODEL 132.001, 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 7, 2003, 118 days after receiving the submission on April 11, 2003. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5700.

Submission Details

510(k) Number K031158 FDA.gov
FDA Decision Cleared SESE
Date Received April 11, 2003
Decision Date August 07, 2003
Days to Decision 118 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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