Cleared Traditional

VIRTUOSO SYSTEM FOR IHC KI-67 (30-9)

K111755 · Ventana Medical Systems, Inc. · Pathology
Feb 2012
Decision
245d
Days
—
Risk

About This 510(k) Submission

K111755 is an FDA 510(k) clearance for the VIRTUOSO SYSTEM FOR IHC KI-67 (30-9), submitted by Ventana Medical Systems, Inc. (Tucso, US). The FDA issued a Cleared decision on February 22, 2012, 245 days after receiving the submission on June 22, 2011. This device falls under the Pathology review panel.

Submission Details

510(k) Number K111755 FDA.gov
FDA Decision Cleared SESE
Date Received June 22, 2011
Decision Date February 22, 2012
Days to Decision 245 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF

Device Classification

Product Code NOT
Device Class —

Similar Devices — NOT

All 11
APERIO EPATHOLOGY EIHC IVD SYSTEM
K141109 · Leica Biosystems Imaging, Inc. · Jul 2014
VIRTUOSO SYSTEM FOR IHC KI-67 (30-9)
K121033 · Ventana Medical Systems, Inc. · Sep 2013
VIRTUSO SYSTEM FOR IHC (DO-7)
K121350 · Ventana Medical Systems, Inc. · Jun 2012
VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5)
K111543 · Ventana Medical Systems, Inc. · Oct 2011
SCANSCOPE XT SYSTEM
K080564 · Aperio Technologies · Aug 2009
PATHIAM SYSTEM FOR HER2/NEU IMMUNOHISTOCHEMISTRY REAGENTS & KITS
K080910 · Bioimagene, Inc. · Feb 2009