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 Aug 20, 2003 as substantially equivalent to K001420 (Applied Imaging Corp., 2000) and 2 other predicates after a 211-day review. Its family tree reaches back 2 generations to 1993. 13 later devices descend from it.
- Decided
- Aug 20, 2003
- Review
- 211 days
- Class
- Class II
- Product code
- JOY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K925670 (1993). 6 ancestors in all, the oldest K902311 (1990). 13 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK925670 IMS-200Intelligent Medica Imaging, Inc. · 1993
- 1 generation backK984188 Automated Cellular Imaging System (Acis)Chroma Vision Medical Systems, Inc. · 1999
- This deviceK030192 Duet SystemBioview, Ltd. · 2003
- Descendant · cites it directly · 12 of its ownK040591 Duet SystemBioview, Ltd. · 2004
- Descendant · cites it directly · 7 of its ownK050840 Modification to Duet SystemBioview, Ltd. · 2005
- Descendant · cites it directly · 5 of its ownK061602 Duet SystemBioview, Ltd. · 2007
- Descendant · 2 generations on · 4 of its ownK050236 FishviewApplied Spectral Imaging, Ltd. · 2005
- Descendant · 3 generations on · 3 of its ownK071398 Scanview, Model SC-300Applied Spectral Imaging, Ltd. · 2007
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K040591Duet SystemBioview, Ltd. · 2004 · cites it directly12descendants
- K050840Modification to Duet SystemBioview, Ltd. · 2005 · cites it directly7descendants
- K061602Duet SystemBioview, Ltd. · 2007 · cites it directly5descendants
- K050236FishviewApplied Spectral Imaging, Ltd. · 2005 · 2 generations on4descendants
- K071398Scanview, Model SC-300Applied Spectral Imaging, Ltd. · 2007 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K925670 | IMS-200 | Intelligent Medica Imaging, Inc. | 1993 | — |
| −1 | K984188 | Automated Cellular Imaging System (Acis) | Chroma Vision Medical Systems, Inc. | 1999 | — |
| 0 (this device) | K030192 | Duet System | Bioview, Ltd. | 2003 | — |
| +1 | K040591 | Duet System | Bioview, Ltd. | 2004 | — |
| +1 | K050840 | Modification to Duet System | Bioview, Ltd. | 2005 | — |
| +1 | K061602 | Duet System | Bioview, Ltd. | 2007 | — |
| +2 | K050236 | Fishview | Applied Spectral Imaging, Ltd. | 2005 | — |
| +3 | K071398 | Scanview, Model SC-300 | Applied Spectral Imaging, Ltd. | 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 |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 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? (4)
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 |
|---|---|---|---|
| * | K001420 | Slidescan | 2000 |
| * | K984188 | Automated Cellular Imaging System (Acis)Summary page 2…ging, Inc., cleared under KO0 1420. ACIS (Automated Cellular Imaging System), manufactured by CromaVisioR Medical Systems, Inc. cleared under K984188. 0 Bandview, manufactured by Applied Spectral Imaging, cleared under KO1 2 103. 0 Human manual visualiza… | 1999 |
| * | K012103 | Bandview System | 2001 |
| * | — | Human manual visualization by conventional microscope Named without a submission number |
What descends from it? (13)
See all 134 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 10 years and passes through 3 companies; a new generation was cleared every 6.0 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K040591 (Bioview, Ltd., 2004) has gone furthest, with 12 descendants of its own.
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 DuetfM system is an automated scanning microscope and image analysis system. It is intended for in-vitro diagnosis use as an aiding tool to the pathologist in the detection, classification and counting of cells of interests based on particular color, intensity, size, pattern and shape.
This particular application is intended to detect hematopoietic cells positively stained by Giemza stain, Immunohistochemistry or ISH (with bright field and fluorescent) prepared from cell suspension. The device can be used without limitation to specific diseases.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030192 · printed Nov 4, 2026
Cite this page
510(k) Report. “K030192: Duet System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K030192
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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