# K073677: Scanscope XT System

- Pathway: 510(k) (Traditional)
- Applicant: Aperio Technologies
- Decided: Aug 1, 2008 after 217 days
- Product code: NQN (Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity)
- 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 K033200 (2004). 1 ancestor in all.
7 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033200: ARIOL, Applied Imaging Corp. (2004) Summary page 2.

## Most influential descendants
- K111869: Virtuoso System for Ihc PR (IE2) (2012), 4 descendants of its own
- K141109: Aperio Epathology Eihc Ivd System (2014), 1 descendant of its own
- K122143: Virtuoso System for Ihc PR (1E2) Benchmark Ultra Stainer (2013), 1 descendant of its own
- K260755: OptraSCAN System (2026), 0 descendants of its own
- K142965: Virtuoso System for IHC PR (1E2) using iScan HT (2015), 0 descendants of its own

## Indications for use
The ScanScope® XT 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 ER Image Analysis application is intended for use as an aid to the pathologist in the detection and quantitative measurement of ER (Estrogen Receptor) in formalin-fixed paraffin-embedded normal and neoplastic tissue. The IHC PR Image Analysis application is intended for use as an aid to the pathologist in the detection and quantitation measurement of PR (Progesterone Receptor) in formalin-fixed, paraffin-embedded normal and neoplastic tissue. It is indicated for use as an aid in the management, prognosis, and prediction of therapy outcomes of breast cancer. Note: The IHC ER and PR Image Analysis applications are 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 estrogen and progesterone receptor proteins. 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 ER and PR reagent/kit used to assure the validity of the IHC ER and PR Image Analysis application assisted scores.

Source page: https://510kreport.com/device/K073677
Methodology: https://510kreport.com/methodology