Cleared Traditional

EMBRACE THERMOPLASTIC

K120335 · Bionix Development Corp. · Radiology
May 2012
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K120335 is an FDA 510(k) clearance for the EMBRACE THERMOPLASTIC, a Accelerator, Linear, Medical (Class II — Special Controls, product code IYE), submitted by Bionix Development Corp. (Toledo, US). The FDA issued a Cleared decision on May 3, 2012, 90 days after receiving the submission on February 3, 2012. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K120335 FDA.gov
FDA Decision Cleared SESE
Date Received February 03, 2012
Decision Date May 03, 2012
Days to Decision 90 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IYE — Accelerator, Linear, Medical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.5050

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