# K111914: Virtual Slide System, Olympus VS800 System

- Pathway: 510(k) (Traditional)
- Applicant: Olympus America Inc. / Scientific Equipment Group
- Decided: Aug 21, 2012 after 412 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: 2 generations back to K032113 (2003). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071671: Scanscope XT System, Aperio Technologies (2007) Summary page 2.

## Most influential descendants
- K130021: Philips Herceptest Digital Score (2013), 0 descendants of its own

## Indications for use
The VS800 system is an automated digital slide creation, management, and viewing 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 VS800HER2 Manual Read (MR) of digital slide application is intended for use as an aid to the pathologist in the detection and semi-quantitative measurement of HER2 by manual examination of the digital slide of formalin-fixed, paraffin-embedded and neoplastic tissue IHC stained for HER2 receptors on a computer monitor. HER2 results are indicated for use as an aid in the management, prognosis and prediction of therapy outcomes of breast cancer- The VS800HER2 MR of digital slide application is intended for use as an accessory to the DakoHercepTest to aid the pathologist in the detection and semi-quantitative measurement of HER2 by manual examination of the digital slide of formalin-fixed, paraffin-embedded and neoplastic tissue immunohistochemically stained for HER2 receptors on a computer monitor. When used with the Dako Hercep Test, 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 Hercep Test to the Herceptin® clinical outcome has not been established.

Source page: https://510kreport.com/device/K111914
Methodology: https://510kreport.com/methodology