Cleared Traditional

K140860 - ImmersiveTouch3 and MicrovisTouch (FDA 510(k) Clearance)

K140860 · Immersivetouch · Radiology device

Dec 2014

Decision

257d

Days

Class 2

Risk

K140860 is an FDA 510(k) clearance for the ImmersiveTouch3 and MicrovisTouch. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Immersivetouch (Westmont, US). The FDA issued a Cleared decision on December 16, 2014, 257 days after receiving the submission on April 3, 2014.

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

Submission Details

510(k) Number	K140860 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 03, 2014
Decision Date	December 16, 2014
Days to Decision	257 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF