Cleared Traditional

ESTEYA

K132092 · Nucletron B.V. · Radiology
Sep 2013
Decision
83d
Days
Class 2
Risk

About This 510(k) Submission

K132092 is an FDA 510(k) clearance for the ESTEYA, a System, Therapeutic, X-ray (Class II — Special Controls, product code JAD), submitted by Nucletron B.V. (Rice Lake, US). The FDA issued a Cleared decision on September 26, 2013, 83 days after receiving the submission on July 5, 2013. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5900.

Submission Details

510(k) Number K132092 FDA.gov
FDA Decision Cleared SESE
Date Received July 05, 2013
Decision Date September 26, 2013
Days to Decision 83 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code JAD — System, Therapeutic, X-ray
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.5900

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