# K071671: Scanscope XT System

- Pathway: 510(k) (Traditional)
- Applicant: Aperio Technologies
- Decided: Dec 28, 2007 after 192 days
- Product code: OEO (Automated Digital Image Manual Interpretation Microscope)
- 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). 1 ancestor in all.
4 later devices descend from it; 4 cite 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.

## Most influential descendants
- K111914: Virtual Slide System, Olympus VS800 System (2012), 1 descendant of its own
- K131140: Omnyx Idp for HER2 Manual Application (2014), 0 descendants of its own
- K130021: Philips Herceptest Digital Score (2013), 0 descendants of its own
- K080254: Scanscope XT System (2008), 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 Manual Read of Digital Slides application is intended for use as an aid to the pathologist in the detection and semi-quantitative measurement of HER-2/neu (c-erbB-2) by manual examination of the digital slide of formalin-fixed, paraffin-embedded normal and neoplastic tissue immunohistochemically stained for HER-2 receptors on a computer monitor. HER-2 results are indicated for use as an aid in the management, prognosis and prediction of therapy outcomes of breast cancer. The IHC HER2 Manual Read of Digital Slides application is intended for use as an accessory to the Dako HercepTest T M to aid the pathologist in the detection and semi-quantitative measurement of HER-2/neu (c-erbB-2) by manual examination of the digital slide of formnalin-fixed, paraffin-embedded normal and neoplastic tissue immunohistochemically stained for HER-2 receptors on a computer monitor. When used with the Dako HercepTestTM, 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 actual correlation of the Dako HercepTest T M to Herceptin® clinical outcome has not been established.

Source page: https://510kreport.com/device/K071671
Methodology: https://510kreport.com/methodology