# K042542: Cytovision for Cep XY

- Pathway: 510(k) (Traditional)
- Applicant: Applied Imaging Corp.
- Decided: Jan 10, 2005 after 112 days
- Product code: NTH (System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays)
- Device class: 2
- Regulation: 21 CFR 866.4700
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K071398: Scanview, Model SC-300 (2007), 3 descendants of its own
- K101291: Scanview HER2/Neu Fish System (2010), 2 descendants of its own
- K110345: Scanview System (2011), 1 descendant of its own
- K122554: Genasis Scanview System (2013), 0 descendants of its own

## Recalls of this device
- May 2, 2016 · Class III · Z-2039-2016: Systems have an improperly activated Windows 7 OS, even though a valid Windows 7 license was associated with each manufactured system. The system appears to be unlicensed. These systems cannot be re-a

## Indications for use
The Applied Imaging CytoVision™ system is an automated scanning microscope and image analysis system. It is intended for in vitro diagnostic use as an aid in chromosomal analysis. CytoVision assists in the location of interphase and metaphase nuclei on standard microscope slides using both brightfield and fluorescent microscopy. This particular CytoVision software application is an accessory to the CEP® X Spectrum Orange™/CEP® Y Spectrum Green™ DNA Probe kit (Vysis, Inc. Downer’s Grove, IL) and is limited to the analysis of CEP XY probes via high magnification capture and analysis of interphase nuclei. CEP XY is indicated for use to assess the effectiveness of bone marrow transplantation in opposite-sex transplants.

Source page: https://510kreport.com/device/K042542
Methodology: https://510kreport.com/methodology