Cleared Traditional

Martinez Prostate Template Set

K142439 · Nucletron B.V. · Radiology
Mar 2015
Decision
193d
Days
Class 2
Risk

About This 510(k) Submission

K142439 is an FDA 510(k) clearance for the Martinez Prostate Template Set, a System, Applicator, Radionuclide, Remote-controlled (Class II — Special Controls, product code JAQ), submitted by Nucletron B.V. (Veenendaal, NL). The FDA issued a Cleared decision on March 10, 2015, 193 days after receiving the submission on August 29, 2014. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5700.

Submission Details

510(k) Number K142439 FDA.gov
FDA Decision Cleared SESE
Date Received August 29, 2014
Decision Date March 10, 2015
Days to Decision 193 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

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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