510(k) · Cleared
ClearedIkoniscope Fastfish Auto/Amniocyte Test System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ikonisys, Inc. · JOY Device, Automated Cell-Locating
Cleared on Aug 1, 2006 as substantially equivalent to K052577 (Ikonisys, Inc., 2006) and 1 other predicate after a 74-day review. Its family tree reaches back 5 generations to 1993. 1 later device descends from it.
- Decided
- Aug 1, 2006
- Review
- 74 days
- Class
- Class II
- Product code
- JOY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K925670 (1993). 9 ancestors in all, the oldest K902311 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK925670 IMS-200Intelligent Medica Imaging, Inc. · 1993
- 4 generations backK984188 Automated Cellular Imaging System (Acis)Chroma Vision Medical Systems, Inc. · 1999
- 3 generations backK030192 Duet SystemBioview, Ltd. · 2003
- 2 generations backK040591 Duet SystemBioview, Ltd. · 2004
- 1 generation backK052577 Ikoniscope Fastfish Amnio Imaging SystemIkonisys, Inc. · 2006
- This deviceK061392 Ikoniscope Fastfish Auto/Amniocyte Test SystemIkonisys, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK062755 Ikoniscope Oncofish Bladder Test SystemIkonisys, Inc. · 2007
Most influential descendants
Showing 1 of 1 · See all- K062755Ikoniscope Oncofish Bladder Test SystemIkonisys, Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K925670 | IMS-200 | Intelligent Medica Imaging, Inc. | 1993 | — |
| −4 | K984188 | Automated Cellular Imaging System (Acis) | Chroma Vision Medical Systems, Inc. | 1999 | — |
| −3 | K030192 | Duet System | Bioview, Ltd. | 2003 | — |
| −2 | K040591 | Duet System | Bioview, Ltd. | 2004 | — |
| −1 | K052577 | Ikoniscope Fastfish Amnio Imaging System | Ikonisys, Inc. | 2006 | — |
| 0 (this device) | K061392 | Ikoniscope Fastfish Auto/Amniocyte Test System | Ikonisys, Inc. | 2006 | — |
| +1 | K062755 | Ikoniscope Oncofish Bladder Test System | Ikonisys, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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 JOY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JOY device
- #1 K243144 X100/X100HT with Full Field Peripheral Blood…score 11.1 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K052577 | Ikoniscope Fastfish Amnio Imaging SystemSummary page 2…T M T M T (K052577); (2) BioView Duet System (K040591) INTENDED USE The Ikoniscope TM fastFISHTM Auto/Amniocyte Test System is an automated scanni… | 2006 |
| * | K040591 | Duet SystemSummary page 2…M T M T (K052577); (2) BioView Duet System (K040591) INTENDED USE The Ikoniscope TM fastFISHTM Auto/Amniocyte Test System is an automated scanning microscope coupled with image an… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062755 | Ikoniscope Oncofish Bladder Test System | 2007 | 0 |
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 13 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K062755 (Ikonisys, Inc., 2007) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K052577.
How does its category compare?
All JOY devicesJOY Device, Automated Cell-Locating: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JOY
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JOY
136in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JOY
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JOY
1in 2025
MAUDE reports naming product code JOY, 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 | 3 | 136 | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 2 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 1 | — | 1 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Ikoniscope fastFISH Auto/Amniocyte Test System is an automated scanning microscope coupled with image analysis, acquisition and display functions. It is intended for in-vitro diagnosis as an aide 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. Following fully automated scanning, the system produces a summary…
Read the full statement (132 words)
The Ikoniscope fastFISH Auto/Amniocyte Test System is an automated scanning microscope coupled with image analysis, acquisition and display functions. It is intended for in-vitro diagnosis as an aide 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. Following fully automated scanning, the system produces a summary report of the frequency of FISH signals detected from each chromosome of interest as a basis for the diagnostic conclusion. The system also provides images of all nuclei scanned for review by the medical professional to confirm the diagnostic conclusion. The Ikoniscope fastFISH Auto/Amniocyte Test System is intended to detect amniotic cells stained by FISH using commercially available direct labeled DNA probes or chromosomes X,Y, 13, 18 and 21.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061392 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061392: Ikoniscope Fastfish Auto/Amniocyte Test System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061392
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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