# K110345: Scanview System

- Pathway: 510(k) (Traditional)
- Applicant: Applied Spectral Imaging
- Decided: Oct 19, 2011 after 257 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: 7 generations back to K925670 (1993). 18 ancestors in all.
1 later device descends 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)
- K101291: Scanview HER2/Neu Fish System, Applied Spectral Imaging, Ltd. (2010) Summary page 1.
- K050840: Modification to Duet System, Bioview, Ltd. (2005) Summary page 1.

## Most influential descendants
- 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 as anl accessory to the following FDA cleared/approved devices to detect the following cell types: 1. CEP® X Spectrum OrangeiM/CEP® Y Spectrum GreenTM' DNA Probe Kit and is limited to the analysis of CEP XY probes via high magnification capture and analysis of inrerphase nuclei. CEP XY is indicated for use to assess the effectiveness of bone marrow transplantation in opposite-sex transplants. 2. Human breast cancer containing the HER-2/neu 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 Vysis® Path VysionTm HER-2 DNA Probe kit. Results f'rom the PathVysionM Kit are intended for use as an adjunct to existing clinical and pathologic information used as prognostic factors in stage 11, node-positive breast cancer patients. The Path Vysion T'" kit is further indicated as an aid to predict disease-free and overall survival in patients with stage 11, node positive breast cancer, treated with adjuvant cyclophosphamide, doxorubicin, and 5-fluorouracil (CAF) chemotherapy. 3. Cells in urine specimens, stained by fluorescence in situ hybridization (FISH) using Vysis UroVysionM Bladder Cancer Kit to detect aneuploidy for chromosomes 3, 7, 17, and loss of the 9p2I locus, from persons with hemnaturia suspected of having bladder cancer. The results are intended for use, in conjunction with and not in lieu of current standard diagnostic procedures, as an aid for initial diagnosis of bladder carcinoma in patients with hemnaturia and subsequent monitoring for tumor recurrence in patients previously diagnosed with bladder cancer. The ScanView System is to be used as an adjunctive automated enumeration tool in conjunction with manual visualization.

Source page: https://510kreport.com/device/K110345
Methodology: https://510kreport.com/methodology