Cleared Traditional

K120367 - 3MENSIO WORKSTATION (FDA 510(k) Clearance)

K120367 · Pie Medical Imaging BV · Radiology device

Apr 2012

Decision

71d

Days

Class 2

Risk

K120367 is an FDA 510(k) clearance for the 3MENSIO WORKSTATION. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Pie Medical Imaging BV (Maastricht, NL). The FDA issued a Cleared decision on April 17, 2012, 71 days after receiving the submission on February 6, 2012.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K120367 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 06, 2012
Decision Date	April 17, 2012
Days to Decision	71 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF