Ventana Medical Systems, Inc. - FDA 510(k) Cleared Devices

Cleared Dec 17, 2024

Roche Digital Pathology Dx

K242783 · PSY

Pathology · 92d

Not Cleared Dec 05, 2024

VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001)

DEN240025 · SDP

Pathology · 190d

Cleared Jun 14, 2024

Roche Digital Pathology Dx (VENTANA DP 200)

K232879 · PSY

Pathology · 270d

Cleared Dec 10, 2021

CINtec Histology

K212176 · PRB

Pathology · 151d

Not Cleared Mar 04, 2017

CINtec Histology (50 tests), CINtec Histology (250 tests)

DEN160019 · PRB

Pathology · 285d

Cleared Jul 16, 2015

Virtuoso System for IHC PR (1E2) using iScan HT

K142965 · OEO

Pathology · 275d

Cleared Mar 20, 2014

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

K140465 · NQN

Pathology · 24d

Cleared Nov 22, 2013

VIRTUOSO SYSTEM FOR IHC ER (SPI)

K130515 · NQN

Pathology · 268d

Cleared Sep 26, 2013

VIRTUOSO SYSTEM FOR IHC HER2 (4B5)

K121516 · NQN

Pathology · 492d

Cleared Sep 19, 2013

VIRTUOSO SYSTEM FOR IHC PR (1E2) BENCHMARK ULTRA STAINER

K122143 · NQN

Pathology · 427d

Cleared Sep 06, 2013

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

K121033 · NOT

Pathology · 519d

Cleared Dec 17, 2012

CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODY

K110215 · MYA

Pathology · 719d

Cleared Jun 01, 2012

VIRTUSO SYSTEM FOR IHC (DO-7)

K121350 · NOT

Pathology · 28d

Cleared Apr 19, 2012

VIRTUOSO SYSTEM FOR IHC P53 (DO-7)

K111872 · NQN

Pathology · 293d

Cleared Mar 05, 2012

VIRTUOSO SYSTEM FOR IHC PR (IE2)

K111869 · NQN

Pathology · 248d

Cleared Feb 22, 2012

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

K111755 · NOT

Pathology · 245d

Cleared Oct 12, 2011

VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5)

K111543 · NOT

Pathology · 132d

Cleared Jul 23, 1999

VENTANA PGR PRIMARY ANTIBODY (CLONE 1A6)

K990618 · MXZ

Pathology · 148d