510(k) · Cleared
ClearedIconoscope Oncofish HER2 Test System, Model 2000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ikonisys, Inc. · NTH System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays
Cleared on Oct 17, 2008 as substantially equivalent to K050840 (Bioview, Ltd., 2005) and 2 other predicates after a 199-day review. Its family tree reaches back 6 generations to 1993.
- Decided
- Oct 17, 2008
- Review
- 199 days
- Class
- Class II
- Product code
- NTH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K925670 (1993). 14 ancestors in all, the oldest K902311 (1990). No later device cites it as a predicate yet.
- Root · 6 generations backK925670 IMS-200Intelligent Medica Imaging, Inc. · 1993
- 5 generations backK984188 Automated Cellular Imaging System (Acis)Chroma Vision Medical Systems, Inc. · 1999
- 4 generations backK030192 Duet SystemBioview, Ltd. · 2003
- 3 generations backK040591 Duet SystemBioview, Ltd. · 2004
- 2 generations backK050840 Modification to Duet SystemBioview, Ltd. · 2005
- 1 generation backK061602 Duet SystemBioview, Ltd. · 2007
- This deviceK080909 Iconoscope Oncofish HER2 Test System, Model 2000Ikonisys, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K925670 | IMS-200 | Intelligent Medica Imaging, Inc. | 1993 | — |
| −5 | K984188 | Automated Cellular Imaging System (Acis) | Chroma Vision Medical Systems, Inc. | 1999 | — |
| −4 | K030192 | Duet System | Bioview, Ltd. | 2003 | — |
| −3 | K040591 | Duet System | Bioview, Ltd. | 2004 | — |
| −2 | K050840 | Modification to Duet System | Bioview, Ltd. | 2005 | — |
| −1 | K061602 | Duet System | Bioview, Ltd. | 2007 | — |
| 0 (this device) | K080909 | Iconoscope Oncofish HER2 Test System, Model 2000 | Ikonisys, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NTH? 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
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K050840 | Modification to Duet SystemSummary page 1…FDA cleared predicate devices with regard to indications for use and technological charecteristics. The predicate devices identified in this submission: Bioview Duet TM (k050840, k061602) (2) Vysis® AutoVysion T M System - K041875 Indications for Use Statement The Ikoniscope oncoFISH her2 Test System is… | 2005 |
| * | K061602 | Duet SystemSummary page 1…ed predicate devices with regard to indications for use and technological charecteristics. The predicate devices identified in this submission: Bioview Duet TM (k050840, k061602) (2) Vysis® AutoVysion T M System - K041875 Indications for Use Statement The Ikoniscope oncoFISH her2 Test System is an automa… | 2007 |
| * | DEN040010 | Vysis Autovysion System Our reading of the summary gave K041875, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN040010, Vysis Autovysion System (Vysis), granted Dec 13, 2004; older De Novo requests were first filed under a 510(k) number, so this links to the grant. | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- 2 of the 14 ancestors have a recall of any class.
- 4 other devices also cite its predicate K050840.
How does its category compare?
All NTH devicesNTH System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · NTH
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · NTH
Too few NTH 510(k)s in any year since 2007 to give a median.
Recalls per year · NTH
No recall names NTH since 2007.
Adverse event reports per year · NTH
1in 2024
MAUDE reports naming product code NTH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Ikoniscope® oncoFISH® her2 Test System is an automated scanning microscope coupled with image analysis, acquisition, and display functions. It is intended for in-vitro diagnosis as an aid to the technologist or pathologist in the detection, classification, and enumeration of cells of interest based on particular characteristics such as intensity, size, shape, or fluorescence. The Ikoniscope® oncoFISH® her2 Test System is intended to detect and…
Read the full statement (131 words)
The Ikoniscope® oncoFISH® her2 Test System is an automated scanning microscope coupled with image analysis, acquisition, and display functions. It is intended for in-vitro diagnosis as an aid to the technologist or pathologist in the detection, classification, and enumeration of cells of interest based on particular characteristics such as intensity, size, shape, or fluorescence. The Ikoniscope® oncoFISH® her2 Test System is intended to detect and quantify chromosome 17 and the HER-2 gene via fluorescence in situ hybridization (FISH) in interphase nuclei from formalin-fixed, paraffin embedded human breast cancer tissue specimens, probed with the Abbott PathVysion® HER-2 DNA Probe Kit. The Ikoniscope® oncoFISH® her2 Test System is to be used as an adjunctive automated enumeration tool, in conjunction with manual visualization, to assist in determining Her-2 gene to chromosome 17 signal ratio.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080909 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080909: Iconoscope Oncofish HER2 Test System, Model 2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080909
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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