# K071398: Scanview, Model SC-300

- Pathway: 510(k) (Traditional)
- Applicant: Applied Spectral Imaging, Ltd.
- Decided: Oct 4, 2007 after 136 days
- Product code: JOY (Device, Automated Cell-Locating)
- 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: 5 generations back to K925670 (1993). 10 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050236: Fishview, Applied Spectral Imaging, Ltd. (2005) Summary page 1.
- K042542: Cytovision for Cep XY, Applied Imaging Corp. (2005) Summary page 1.

## Most influential descendants
- 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 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: 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/K071398
Methodology: https://510kreport.com/methodology