Cleared Traditional

Geneva

K201272 · Nucletron B.V. · Radiology
Jul 2020
Decision
65d
Days
Class 2
Risk

About This 510(k) Submission

K201272 is an FDA 510(k) clearance for the Geneva, 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 July 16, 2020, 65 days after receiving the submission on May 12, 2020. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5700.

Submission Details

510(k) Number K201272 FDA.gov
FDA Decision Cleared SESE
Date Received May 12, 2020
Decision Date July 16, 2020
Days to Decision 65 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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