# K101291: Scanview HER2/Neu Fish System

- Pathway: 510(k) (Traditional)
- Applicant: Applied Spectral Imaging, Ltd.
- Decided: Nov 23, 2010 after 200 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K925670 (1993). 17 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071398: Scanview, Model SC-300, Applied Spectral Imaging, Ltd. (2007) Summary page 1.
- K061602: Duet System, Bioview, Ltd. (2007) Summary page 1.

## Most influential descendants
- K110345: Scanview System (2011), 1 descendant of its own
- K122554: Genasis Scanview System (2013), 0 descendants of its own

## Indications for use
The ScanView System is an automated scanning microscope and image analysis system. It is intended for in-vitro diagnostic use as an aiding tool to the pathologist or cytogeneticist in the detection, classification and enumeration of cells of interest based on color, intensity, size, pattern, and shape. The ScanView is indicated to detect the following cell types: 1. CliP® X Spectrum Orangerm/CEP® Y Spectrum GreenTm DNA Probe kit (Abbott Laboratories, Illinois, U.S.A) and is limited to the analysis of CEiP XY probes via high magnification capture and analysis of interphase nuclei. CEiP XY is indicated for use to assess the effectiveness of bone marrow transplantation in opposite-sex transplants 2. Human breast cancer containing the HER-2lneu gene labeled in Red and the centromere of chromosome 17 labeled in Green via fluorescence in situ hybridization (FISH) in interphase nuclei from formalin-fixed, paraffin embedded human breast cancer tissue specimens with the Vysis® Path VysionTM HER-2 DNA Probe kit. The ScanView System is to be used as an adjunctive automated enumeration tool in conjunction with manual visualization.

Source page: https://510kreport.com/device/K101291
Methodology: https://510kreport.com/methodology