Cleared Traditional

Esteya

K213942 · Nucletron B.V. · Radiology
Jan 2022
Decision
25d
Days
Class 2
Risk

About This 510(k) Submission

K213942 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. (Veenendaal, NL). The FDA issued a Cleared decision on January 11, 2022, 25 days after receiving the submission on December 17, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5900.

Submission Details

510(k) Number K213942 FDA.gov
FDA Decision Cleared SESE
Date Received December 17, 2021
Decision Date January 11, 2022
Days to Decision 25 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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