Cleared Traditional

K120484 - VISIA ONCOLOGY (FDA 510(k) Clearance)

K120484 · Mevis Medical Solutions AG · Radiology device

Mar 2012

Decision

39d

Days

Class 2

Risk

K120484 is an FDA 510(k) clearance for the VISIA ONCOLOGY. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Mevis Medical Solutions AG (Pewaukee, US). The FDA issued a Cleared decision on March 27, 2012, 39 days after receiving the submission on February 17, 2012.

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

Submission Details

510(k) Number	K120484 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 17, 2012
Decision Date	March 27, 2012
Days to Decision	39 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF