Cleared Traditional

K153736 - 3mensio Workstation (FDA 510(k) Clearance)

K153736 · Pie Medical Imaging BV · Radiology device

May 2016

Decision

151d

Days

Class 2

Risk

K153736 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 May 27, 2016, 151 days after receiving the submission on December 28, 2015.

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

Submission Details

510(k) Number	K153736 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 28, 2015
Decision Date	May 27, 2016
Days to Decision	151 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF