510(k) · Cleared
ClearedDuet System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bioview, Ltd. · JOY Device, Automated Cell-Locating
Cleared on Jan 23, 2007 as substantially equivalent to K030192 (Bioview, Ltd., 2003) and 4 other predicates after a 229-day review. Its family tree reaches back 5 generations to 1993. 5 later devices descend from it.
- Decided
- Jan 23, 2007
- Review
- 229 days
- Class
- Class II
- Product code
- JOY
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 5 generations to K925670 (1993). 13 ancestors in all, the oldest K902311 (1990). 5 later devices descend from it, 3 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 backK050840 Modification to Duet SystemBioview, Ltd. · 2005
- This deviceK061602 Duet SystemBioview, Ltd. · 2007
- Descendant · cites it directly · 2 of its ownK101291 Scanview HER2/Neu Fish SystemApplied Spectral Imaging, Ltd. · 2010
- Descendant · 2 generations on · 1 of its ownK110345 Scanview SystemApplied Spectral Imaging · 2011
- Descendant · cites it directly · 0 of its ownK130775 Duet SystemBioview, Ltd. · 2014
- Descendant · 3 generations on · 0 of its ownK122554 Genasis Scanview SystemApplied Spectral Imaging, Ltd. · 2013
- Descendant · cites it directly · 0 of its ownK080909 Iconoscope Oncofish HER2 Test System, Model 2000Ikonisys, Inc. · 2008
Most influential descendants
Showing 5 of 5 · See all- K101291Scanview HER2/Neu Fish SystemApplied Spectral Imaging, Ltd. · 2010 · cites it directly2descendants
- K110345Scanview SystemApplied Spectral Imaging · 2011 · 2 generations on1descendant
- K130775Duet SystemBioview, Ltd. · 2014 · cites it directly0descendants
- K122554Genasis Scanview SystemApplied Spectral Imaging, Ltd. · 2013 · 3 generations on0descendants
- K080909Iconoscope Oncofish HER2 Test System, Model 2000Ikonisys, Inc. · 2008 · 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 | K050840 | Modification to Duet System | Bioview, Ltd. | 2005 | — |
| 0 (this device) | K061602 | Duet System | Bioview, Ltd. | 2007 | — |
| +1 | K101291 | Scanview HER2/Neu Fish System | Applied Spectral Imaging, Ltd. | 2010 | — |
| +2 | K110345 | Scanview System | Applied Spectral Imaging | 2011 | — |
| +1 | K130775 | Duet System | Bioview, Ltd. | 2014 | — |
| +3 | K122554 | Genasis Scanview System | Applied Spectral Imaging, Ltd. | 2013 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 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? (6)
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 |
|---|---|---|---|
| * | K030192 | Duet SystemSummary page 2…devices and a standard procedure for the current DuetTM System substantial equivalence discussion: ' DuetTM System, manufactured by BioView Ltd., cleared under K030192, K040591 and K050840 (Product codes JOY and NTH) * Ariol® HER-2/neu FISH, manufactured by Applied Imaging Corp., cleared und… | 2003 |
| * | K040591 | Duet SystemSummary page 2…and a standard procedure for the current DuetTM System substantial equivalence discussion: ' DuetTM System, manufactured by BioView Ltd., cleared under K030192, K040591 and K050840 (Product codes JOY and NTH) * Ariol® HER-2/neu FISH, manufactured by Applied Imaging Corp., cleared under K04351… | 2004 |
| * | K050840 | Modification to Duet SystemSummary page 2…ard procedure for the current DuetTM System substantial equivalence discussion: ' DuetTM System, manufactured by BioView Ltd., cleared under K030192, K040591 and K050840 (Product codes JOY and NTH) * Ariol® HER-2/neu FISH, manufactured by Applied Imaging Corp., cleared under K043519 (product c… | 2005 |
| * | K043519 | Ariol Her-2/Neu FishSummary page 2…oView Ltd., cleared under K030192, K040591 and K050840 (Product codes JOY and NTH) * Ariol® HER-2/neu FISH, manufactured by Applied Imaging Corp., cleared under K043519 (product code NTH) * Vysis® AutoVysionTM System, manufactured by Vysis Inc., cleared under K041875 (product code NTH) * Hum… | 2005 |
| * | 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 |
| * | — | Human manual visualization of human breast cancer tissue specimens, probed by Vysis®… Named without a submission number |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 3 companies; a new generation was cleared every 1.4 years on median.
- 2 of the 13 ancestors have a recall of any class.
- Of its descendants, K101291 (Applied Spectral Imaging, Ltd., 2010) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K030192.
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 DuetTM System is an automated scanning microscope and image analysis system. It is intended for in vitro diagnostic use as an aiding tool to the pathologist in the detection, classification and counting of cells of interest based on color, intensity, size, pattern, and shape. The DuetTM System is intended to: Detect Hematopoietic cells stained by Giemsa stain, Immunohistochemistry or ISH (with bright field and fluorescent) prepared from cell…
Read the full statement (186 words)
The DuetTM System is an automated scanning microscope and image analysis system. It is intended for in vitro diagnostic use as an aiding tool to the pathologist in the detection, classification and counting of cells of interest based on color, intensity, size, pattern, and shape. The DuetTM System is intended to:
Detect Hematopoietic cells stained by Giemsa stain, Immunohistochemistry or ISH (with bright field and fluorescent) prepared from cell suspension.
Detect amniotic cells stained by FISH (using direct labeled DNA probes for chromosomes X, Y, 13, 18 and 21).
Detect cells in urine specimens, stained by FISH (using the Vysis UroVysionTM Bladder Cancer Recurrence Kit for chromosomes 3, 7, 17 and 9p2l locus), from subjects with transitional cell carcinoma of the bladder.
Detect and quantify chromosome 17 and the HER-2/neit gene via fluorescence in situ hybridization (FISH) in interphase nuclei from formalin-fixed, paraffin embedded human breast cancer tissue specimens, probed by the Vysis® PathVysionTM HER-2 DNA Probe Kit. The DuetTM is to be used as an adjunctive automated enumeration tool, in conjunction with manual visualization, to assist in determining HER-2/neu gene to chromosome 17 signal ratio.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061602 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061602: Duet System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061602
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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