CYTOVISION FOR CEP XY— 510(k) K042542

Substantially Equivalent

Applied Imaging Corp.

FDA 510(k) clearance K042542 for CYTOVISION FOR CEP XY, Substantially Equivalent on 2005-01-10. Applicant: Applied Imaging Corp.. Device class: 2.

Clearance details

Applicant: Applied Imaging Corp.
Product code: Code NTH
Device class: Class 2
Regulation: 21 CFR 866.4700
Advisory panel: Immunology
Date received: 2004-09-20
Decision date: 2005-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NTH

K130775 — DUET SYSTEM2014-05-09
K122554 — GENASIS SCANVIEW SYSTEM2013-02-07
K110345 — SCANVIEW SYSTEM2011-10-19
K101291 — SCANVIEW HER2/NEU FISH SYSTEM2010-11-23
K080909 — ICONOSCOPE ONCOFISH HER2 TEST SYSTEM, MODEL 20002008-10-17

More clearances from Applied Imaging Corp.

K043519 — ARIOL HER-2/NEU FISH2005-04-25
K033200 — ARIOL2004-03-18
K031715 — ARIOL HER-2/NEU IHC2004-01-08
K001420 — SLIDESCAN2000-08-30
K980375 — WINSCAN AUTOMATED IMAGING SYSTEM1998-06-09

Recalls naming K042542

K-number listed on FDA's recall record

Z-2039-2016 — CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern.Class III·Terminated·Leica Biosystems Richmond Inc.·20160502

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K042542.

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