Cleared Special

Fiducial Marker

K211590 · Carbon Medical Technologies, Inc. · Radiology
Jun 2021
Decision
17d
Days
Class 2
Risk

About This 510(k) Submission

K211590 is an FDA 510(k) clearance for the Fiducial Marker, a Accelerator, Linear, Medical (Class II — Special Controls, product code IYE), submitted by Carbon Medical Technologies, Inc. (St, Paul, US). The FDA issued a Cleared decision on June 10, 2021, 17 days after receiving the submission on May 24, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K211590 FDA.gov
FDA Decision Cleared SESE
Date Received May 24, 2021
Decision Date June 10, 2021
Days to Decision 17 days
Submission Type Special
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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