Cleared Traditional

K110772 - BIOMARC FIDUCIAL MARKER (FDA 510(k) Clearance)

K110772 · Carbon Medical Technologies, Inc. · Radiology device

Apr 2011

Decision

38d

Days

Class 2

Risk

K110772 is an FDA 510(k) clearance for the BIOMARC FIDUCIAL MARKER. This device is classified as 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 April 28, 2011, 38 days after receiving the submission on March 21, 2011.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number	K110772 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 21, 2011
Decision Date	April 28, 2011
Days to Decision	38 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF