# K033200: ARIOL

- Pathway: 510(k) (Traditional)
- Applicant: Applied Imaging Corp.
- Decided: Mar 18, 2004 after 168 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 1 cites 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K073677: Scanscope XT System (2008), 7 descendants of its own
- 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

## Recalls of this device
- May 6, 2016 · Class III · Z-1948-2016: An issue during the manufacturing process caused systems to have an improperly activated Windows 7 OS, even though a valid Windows 7 license was associated with each manufactured system.

## Indications for use
Ariol TM is an automated scanning microscope and image analysis system. It is intended for in vitro diagnostic use as an aid to the pathologist in the detection, classification, and counting of cells of interest based on particular color, intensity, size, pattern, and shape, This particular Ariol software application is intended to measure, count, and quantitate the percentage and intensity of positively stained nuclei in formalin-fixed paraffin-embedded tissue specimens immunohistochemically stained for Estrogens Receptors or Progesterone Receptors (ER/PR). ER/PR results are indicated for use as and aid in the management, prognosis, and prediction of therapy outcomes of breast cancer.

Source page: https://510kreport.com/device/K033200
Methodology: https://510kreport.com/methodology