Cleared Traditional

RT Elements (4.0)

K223279 · Brainlab AG · Radiology
Mar 2023
Decision
141d
Days
Class 2
Risk

About This 510(k) Submission

K223279 is an FDA 510(k) clearance for the RT Elements (4.0), a System, Planning, Radiation Therapy Treatment (Class II — Special Controls, product code MUJ), submitted by Brainlab AG (Munich, DE). The FDA issued a Cleared decision on March 14, 2023, 141 days after receiving the submission on October 24, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K223279 FDA.gov
FDA Decision Cleared SESE
Date Received October 24, 2022
Decision Date March 14, 2023
Days to Decision 141 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code MUJ — System, Planning, Radiation Therapy Treatment
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.5050

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