510(k) · Cleared
ClearedIkoniscope Oncofish Bladder 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 Jan 4, 2007 as substantially equivalent to K052577 (Ikonisys, Inc., 2006) and 2 other predicates after a 112-day review. Its family tree reaches back 6 generations to 1993.
- Decided
- Jan 4, 2007
- Review
- 112 days
- Class
- Class II
- Product code
- JOY
- 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 backK052577 Ikoniscope Fastfish Amnio Imaging SystemIkonisys, Inc. · 2006
- 1 generation backK061392 Ikoniscope Fastfish Auto/Amniocyte Test SystemIkonisys, Inc. · 2006
- This deviceK062755 Ikoniscope Oncofish Bladder Test SystemIkonisys, Inc. · 2007
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 | K052577 | Ikoniscope Fastfish Amnio Imaging System | Ikonisys, Inc. | 2006 | — |
| −1 | K061392 | Ikoniscope Fastfish Auto/Amniocyte Test System | Ikonisys, Inc. | 2006 | — |
| 0 (this device) | 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 | 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 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? (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 |
|---|---|---|---|
| * | K052577 | Ikoniscope Fastfish Amnio Imaging SystemSummary page 2…ard to indications for use and technological characteristics. The predicate devices identified in this submission: (1) Ikoniscope® fastFISHTM Auto/Amniocyte Test System (K052577); (2) BioView Duet TM (K050840) INTENDED USE The Ikoniscope® oncoFISHTM Bladder Test System is an automated scanning microscope… | 2006 |
| * | K050840 | Modification to Duet SystemSummary page 2…technological characteristics. The predicate devices identified in this submission: (1) Ikoniscope® fastFISHTM Auto/Amniocyte Test System (K052577); (2) BioView Duet TM (K050840) INTENDED USE The Ikoniscope® oncoFISHTM Bladder Test System is an automated scanning microscope coupled with image analysis, a… | 2005 |
| * | K061392 | Ikoniscope Fastfish Auto/Amniocyte Test SystemSummary page 4…cations for use. TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION The Ikoniscope® oncoFISHTM Bladder Test System was evaluated against the predicate device (K061392) using a Nucleus Specific Accuracy Test (Fish dot counting). The results are similar to those obtained for the Predicate device (… | 2006 |
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 14 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- 1 of the 14 ancestors has a recall of any class.
- 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. 2007, this device’s year, is highlighted.
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® oncoFISHTM Bladder 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. The Ikoniscope® oncoFISHTM Bladder Test System is intended to detect…
Read the full statement (130 words)
The Ikoniscope® oncoFISHTM Bladder 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. The Ikoniscope® oncoFISHTM Bladder Test System is intended to detect cells, derived from urine samples, stained by FISH using commercially available direct labeled DNA probes for chromosomes 3, 7, 17 and loss of 9p21 locus. Following identification, a summary report is generated which may provide the basis for a diagnostic determination by the genetics professional and a gallery of the images scanned is presented for review to permit the professional to confirm or deny the diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062755 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062755: Ikoniscope Oncofish Bladder 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/K062755
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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