# K122554: Genasis Scanview System

- Pathway: 510(k) (Traditional)
- Applicant: Applied Spectral Imaging, Ltd.
- Decided: Feb 7, 2013 after 170 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: 8 generations back to K925670 (1993). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110345: Scanview System, Applied Spectral Imaging (2011) Summary page 3.

## Indications for use
The GenASis 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 GenASIs ScanView System is indicated as an accessory to the following FDA cleared/approved devices to detect the following cell types: 1. CEP® X Spectrum Orange TM/CEPS Y Spectrum Greenm DNA Probe Kit 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. 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 Vysion T 'HER-2 DNA Probe kit. Results from 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 Tm 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 UroVysion Tm Bladder Cancer Kit to detect aneuploidy for chromosomes 3, 7, 17, and loss of the 9p2l locus, from persons with hematuria 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 hematuria and subsequent monitoring for tumor recurrence in patients previously diagnosed with bladder cancer. 4. Gene rearrangements involving the ALK gene (2 p2 3 ) via fluorescence in situ hybridization (FISH) in formalin-fixed paraffin-embedded (FEPE) non-small cell lung cancer (NSCLC) tissue specimens, using Vysisg ALK (Anaplastic Lymphoma Kinase) Break Apart FISH Probe kit. The Vysis ALK Break Apart FISH Probe Kit is indicated to aid in identifying those patients eligible for treatment with XALKORI@ (crizotinib). The GenASIs ALK System is an accessory to Vysis® ALK (Anaplastic Lymphoma Kinase) Break Apart FISH Probe kit. The GenASIs ScanView System is to be used as an adjunctive automated enumeration tool in conjunction with manual visualization.

Source page: https://510kreport.com/device/K122554
Methodology: https://510kreport.com/methodology