Cleared Traditional

BIOMARC FIDUCIAL MARKER

K132064 · Carbon Medical Technologies, Inc. · Radiology
Feb 2014
Decision
240d
Days
Class 2
Risk

About This 510(k) Submission

K132064 is an FDA 510(k) clearance for the BIOMARC 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 February 28, 2014, 240 days after receiving the submission on July 3, 2013. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K132064 FDA.gov
FDA Decision Cleared SESE
Date Received July 03, 2013
Decision Date February 28, 2014
Days to Decision 240 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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