# K050236: Fishview

- Pathway: 510(k) (Traditional)
- Applicant: Applied Spectral Imaging, Ltd.
- Decided: Jun 27, 2005 after 147 days
- Product code: LNJ (Analyzer, Chromosome, Automated)
- Device class: 2
- Regulation: 21 CFR 864.5260
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K925670 (1993). 8 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012103: Bandview System, Applied Spectral Imaging, Ltd. (2001) Summary page 1.
- K040591: Duet System, Bioview, Ltd. (2004) Summary page 1.

## 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

## Indications for use
The FISHView system is intended to be used for karyotyping with real-time microscope images from cultured and stained cell specimens in their metaphase. The system works with bright field and fluorescent samples. Specimens suitable for banding analysis are: amniotic fluid, peripheral blood, chorionic villus, bone marrow and solid tumor. Karyotyping is normally applied for the pre and postnatal diagnosis of birth defects, chromosome abnormalities, genetic diseases (such as Down's syndrome), cancer, and for the follow up of the cancer treatment. The FISHView system does not locate metaphase spreads; it does not rank the given cells according to quality; nor does it automatically classify chromosomes. In addition the FISHView is intended as an aiding tool to the pathologist or cytogeneticist for digital visualizing, processing, counting and classification of stained cells and for storage of FISH multi-dye images of the following specimens: amniotic fluid, peripheral blood, chorionic villus, bone marrow and solid tumor. The FISHView system does require and relies on the operator to analyze the digitized microscope images.

Source page: https://510kreport.com/device/K050236
Methodology: https://510kreport.com/methodology