# K080564: Scanscope XT System

- Pathway: 510(k) (Traditional)
- Applicant: Aperio Technologies
- Decided: Aug 14, 2009 after 533 days
- Product code: NOT (Microscope, Automated, Image Analysis, Operator Intervention)
- Device class: 2
- Regulation: 21 CFR 864.1860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K032113 (2003). 2 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032113: Acis (Automated Cellular Imaging System), Chroma Vision Medical Systems, Inc. (2003) Summary page 2.
- K031715: Ariol Her-2/Neu Ihc, Applied Imaging Corp. (2004) Summary page 2.

## Most influential descendants
- K111543: Virtuoso (TM) System for Ihc HER2 (4B5) (2011), 2 descendants of its own
- K140957: Genasis Hipath Ihc Family (2015), 0 descendants of its own
- K131140: Omnyx Idp for HER2 Manual Application (2014), 0 descendants of its own

## Indications for use
The ScanScope System is an automated digital slide creation, management, viewing and analysis system. It is intended for in vitro diagnostic use as an aid to the pathologist in the display, detection, counting and classification of tissues and cells of clinical interest based on particular color, intensity, size, pattern and shape. The IHC HER2 Breast Tissue Tunable Image Analysis application is intended for use as an aid to the pathologist in the detection and semi-quantitative measurement of HER2/neu (c-erbB-2) in formalin-fixed, paraffin-embedded normal and neoplastic tissue. The IHC HER2 Breast Tissue Tunable Image Analysis application is intended for use as an accessory to the Dako HercepTestTM to aid in the detection and semi-quantitative measurement of HER2/neu (c-erbB-2) in formalin-fixed, paraffin-embedded normal and neoplastic tissue. It is indicated for use as an aid in the assessment of breast cancer patients for whom HERCEPTIN® (Trastuzumab) treatment is being considered. Note: The IHC HER2 Breast Tissue Tunable Image Analysis application is an adjunctive computer-assisted methodology to assist the reproducibility of a qualified pathologist in the acquisition and measurement of images from microscope slides of breast cancer specimens stained for the presence of HER2 receptor protein. The accuracy of the test result depends upon the quality of the immunohistochemical staining. It is the responsibility of a qualified pathologist to employ appropriate morphological studies and controls as specified in the instructions for the HER2 reagent/kit used to assure the validity of the IHC HER2 Breast Tissue Tunable Image Analysis application assisted HER2/neu score. The actual correlation of the HER2 reagents/kits to Herceptin® clinical outcome has not been established.

Source page: https://510kreport.com/device/K080564
Methodology: https://510kreport.com/methodology