Cleared Traditional

VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINER

K140465 · Ventana Medical Systems, Inc. · Pathology

Mar 2014

Decision

24d

Days

Class 2

Risk

About This 510(k) Submission

K140465 is an FDA 510(k) clearance for the VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINER, a Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity (Class II — Special Controls, product code NQN), submitted by Ventana Medical Systems, Inc. (Mountain View, US). The FDA issued a Cleared decision on March 20, 2014, 24 days after receiving the submission on February 24, 2014. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1860.

Submission Details

510(k) Number	K140465 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 24, 2014
Decision Date	March 20, 2014
Days to Decision	24 days
Submission Type	Traditional
Review Panel	Pathology (PA)
Summary	Summary PDF

Device Classification

Product Code	NQN — Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 864.1860
Definition	Automated Microscopic Immunohistochemistry Image- Analysis System To Measure Nuclear Intensity And Percent Positivity With Operator Intervention.