VENTANA IMAGE ANALYSIS SYSTEM - HER2/NEU— 510(k) K051282

Name: FDA 510(k) clearance K051282
Creator: U.S. Food and Drug Administration
Published: 2005-08-16

Substantially Equivalent

Tripath Imaging, Inc.

FDA 510(k) clearance K051282 for VENTANA IMAGE ANALYSIS SYSTEM - HER2/NEU, Substantially Equivalent on 2005-08-16. Applicant: Tripath Imaging, Inc.. Device class: 2.

Clearance details

Applicant: Tripath Imaging, Inc.
Product code: Code NOT
Device class: Class 2
Regulation: 21 CFR 864.1860
Advisory panel: Hematology
Date received: 2005-05-17
Decision date: 2005-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NOT

view all

K260755 — OptraSCAN System2026-07-02
K141109 — APERIO EPATHOLOGY EIHC IVD SYSTEM2014-07-29
K121033 — VIRTUOSO SYSTEM FOR IHC KI-67 (30-9)2013-09-06
K121350 — VIRTUSO SYSTEM FOR IHC (DO-7)2012-06-01
K111755 — VIRTUOSO SYSTEM FOR IHC KI-67 (30-9)2012-02-22

More clearances from Tripath Imaging, Inc.

view all

K062428 — VENTANA IMAGE ANALYSIS SYSTEM, MODEL VIAS2006-09-29
K053520 — VENTANA IMAGE ANALYSIS SYSTEM, MODEL KI-672006-04-11
K050012 — VENTANA IMAGE ANALYSIS SYSTEM2005-05-06

Data sourced from openFDA. This site is unofficial and independent of the FDA.