510(k) · Cleared
ClearedGenevision - Computer Assisted Chromosome Karyo.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Applied Imaging Corp. · LNJ Analyzer, Chromosome, Automated
Cleared on Aug 20, 1990 after an 89-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 15 later devices descend from it.
- Decided
- Aug 20, 1990
- Review
- 89 days
- Class
- Class II
- Product code
- LNJ
- Recalls
- None
- Predicates
- 0
15 later devices descend from it, 1 citing it directly.
- This deviceK902311 Genevision - Computer Assisted Chromosome Karyo.Applied Imaging Corp. · 1990
- Descendant · cites it directly · 14 of its ownK012103 Bandview SystemApplied Spectral Imaging, Ltd. · 2001
- Descendant · 2 generations on · 13 of its ownK030192 Duet SystemBioview, Ltd. · 2003
- Descendant · 2 generations on · 12 of its ownK040591 Duet SystemBioview, Ltd. · 2004
- Descendant · 3 generations on · 7 of its ownK050840 Modification to Duet SystemBioview, Ltd. · 2005
- Descendant · 3 generations on · 5 of its ownK061602 Duet SystemBioview, Ltd. · 2007
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K012103Bandview SystemApplied Spectral Imaging, Ltd. · 2001 · cites it directly14descendants
- K030192Duet SystemBioview, Ltd. · 2003 · 2 generations on13descendants
- K040591Duet SystemBioview, Ltd. · 2004 · 2 generations on12descendants
- K050840Modification to Duet SystemBioview, Ltd. · 2005 · 3 generations on7descendants
- K061602Duet SystemBioview, Ltd. · 2007 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K902311 | Genevision - Computer Assisted Chromosome Karyo. | Applied Imaging Corp. | 1990 | — |
| +1 | K012103 | Bandview System | Applied Spectral Imaging, Ltd. | 2001 | — |
| +2 | K030192 | Duet System | Bioview, Ltd. | 2003 | — |
| +2 | K040591 | Duet System | Bioview, Ltd. | 2004 | — |
| +3 | K050840 | Modification to Duet System | Bioview, Ltd. | 2005 | — |
| +3 | K061602 | Duet System | Bioview, Ltd. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LNJ? 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (15)
See all 151 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K012103 | Bandview System | 2001 | 14 |
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?
- Of its descendants, K012103 (Applied Spectral Imaging, Ltd., 2001) has gone furthest, with 14 descendants of its own.
How does its category compare?
All LNJ devicesLNJ Analyzer, Chromosome, Automated: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LNJ
FDA has decided no LNJ device since 2007.
Median 510(k) review, days · LNJ
Too few LNJ 510(k)s in any year since 2007 to give a median.
Recalls per year · LNJ
No recall names LNJ since 2007.
Adverse event reports per year · LNJ
1in 2007
MAUDE reports naming product code LNJ, 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 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 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 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K902311 · printed Nov 6, 2026
Cite this page
510(k) Report. “K902311: Genevision - Computer Assisted Chromosome Karyo..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K902311
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026