510(k) Report

510(k) · Cleared

Recalled · Class III · 2016

ARIOL

K033200510(k) TraditionalCleared Mar 18, 2004168-day reviewClass II21 CFR 864.1860Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Applied Imaging Corp. · NQN Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity

Cleared on Mar 18, 2004 after a 168-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 8 later devices descend from it. It has been recalled once.

Decided
Mar 18, 2004
Review
168 days
Class
Class II
Product code
NQN
Recalls
1
Predicates
0

8 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2008: 1 descendant cleared2014: 1 descendant cleared2012: 1 descendant cleared2015: 2 descendants cleared2013: 2 descendants cleared2026: 1 descendant cleared200020052010201520202025
  1. This deviceK033200 ARIOLApplied Imaging Corp. · 2004
  2. Descendant · cites it directly · 7 of its ownK073677 Scanscope XT SystemAperio Technologies · 2008
  3. Descendant · 2 generations on · 4 of its ownK111869 Virtuoso System for Ihc PR (IE2)Ventana Medical Systems, Inc. · 2012
  4. Descendant · 2 generations on · 1 of its ownK141109 Aperio Epathology Eihc Ivd SystemLeica Biosystems Imaging, Inc. · 2014 · Recalled
  5. Descendant · 3 generations on · 1 of its ownK122143 Virtuoso System for Ihc PR (1E2) Benchmark Ultra StainerVentana Medical Systems, Inc. · 2013
  6. Descendant · 3 generations on · 0 of its ownK260755 OptraSCAN SystemOptrascan, Inc. · 2026

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2008: 12012: 12013: 22014: 12015: 22026: 1
2008high 2 (2013) · low 0 (2009)2026

Most influential descendants

Showing 5 of 8 · See all
  • K073677Scanscope XT SystemAperio Technologies · 2008 · cites it directly7descendants
  • K111869Virtuoso System for Ihc PR (IE2)Ventana Medical Systems, Inc. · 2012 · 2 generations on4descendants
  • K141109Aperio Epathology Eihc Ivd SystemLeica Biosystems Imaging, Inc. · 2014 · 2 generations on1descendant
  • K122143Virtuoso System for Ihc PR (1E2) Benchmark Ultra StainerVentana Medical Systems, Inc. · 2013 · 3 generations on1descendant
  • K260755OptraSCAN SystemOptrascan, Inc. · 2026 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K033200ARIOLApplied Imaging Corp.2004—
+1K073677Scanscope XT SystemAperio Technologies2008—
+2K111869Virtuoso System for Ihc PR (IE2)Ventana Medical Systems, Inc.2012—
+2K141109Aperio Epathology Eihc Ivd SystemLeica Biosystems Imaging, Inc.20141
+3K122143Virtuoso System for Ihc PR (1E2) Benchmark Ultra StainerVentana Medical Systems, Inc.2013—
+3K260755OptraSCAN SystemOptrascan, Inc.2026—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201210
201320
201410
201520
202610
FIG. 1 — Lineage of K033200, 2004–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in NQN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (8)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K073677Scanscope XT SystemAperio Technologies20087

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
May 6, 2016Class IIIZ-1948-2016Nonconforming Material/ComponentAn 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.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K073677 (Aperio Technologies, 2008) has gone furthest, with 7 descendants of its own.

How does its category compare?

All NQN devices

NQN Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NQN

1in 2015

2007: 12008: 12010: 12012: 22013: 32014: 12015: 1
2007high 3 (2013) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NQN

427in 2013

2013: 427 days median
2007high 427 (2013)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NQN

1in 2020

2007: 12008: 12020: 1
2007high 1 (2007) · low 0 (2009)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NQN

1in 2023

2016: 12017: 12020: 12023: 1
2007high 1 (2016) · low 0 (2007)2025

MAUDE reports naming product code NQN, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—10
20081—10
20090—00
20101—00
20110—00
20122—00
2013342700
20141—00
20151—00
20160—01
20170—01
20180—00
20190—00
20200—11
20210—00
20220—00
20230—01
20240—00
20250—00
20260—0—

What is it indicated for?

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.

Indications for use as stated in the FDA 510(k) statement.

More from Applied Imaging Corp.

7 FDA decisions under this applicant name. See the company

  • K043519Ariol Her-2/Neu FishApplied Imaging Corp. · 20051 recall
  • K042542Cytovision for Cep XYApplied Imaging Corp. · 20051 recall
  • K031715Ariol Her-2/Neu IhcApplied Imaging Corp. · 20041 recall
  • K001420SlidescanApplied Imaging Corp. · 2000
  • K980375Winscan Automated Imaging SystemApplied Imaging Corp. · 1998

Recent decisions in NQN

The NQN category page

  • K140957Genasis Hipath Ihc FamilyApplied Spectral Imaging, Ltd. · 2015
  • K140465Virtuoso System for Ihc ER (SP1) with Benchmark Ultra StainerVentana Medical Systems, Inc. · 20141 recall
  • K130515Virtuoso System for Ihc ER (Spi)Ventana Medical Systems, Inc. · 2013
  • K121516Virtuoso System for Ihc HER2 (4B5)Ventana Medical Systems, Inc. · 2013
  • K122143Virtuoso System for Ihc PR (1E2) Benchmark Ultra StainerVentana Medical Systems, Inc. · 2013

https://510kreport.com/device/K033200 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033200: ARIOL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033200

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026