510(k) · Cleared
ClearedBandview System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Applied Spectral Imaging, Ltd. · LNJ Analyzer, Chromosome, Automated
Cleared on Sep 14, 2001 as substantially equivalent to K940240 (Metasystems GmbH, 1995) and 1 other predicate after a 71-day review. Its family tree reaches back 1 generation to 1990. 14 later devices descend from it.
- Decided
- Sep 14, 2001
- Review
- 71 days
- Class
- Class II
- Product code
- LNJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K902311 (1990). 2 ancestors in all. 14 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK902311 Genevision - Computer Assisted Chromosome Karyo.Applied Imaging Corp. · 1990
- This deviceK012103 Bandview SystemApplied Spectral Imaging, Ltd. · 2001
- Descendant · cites it directly · 13 of its ownK030192 Duet SystemBioview, Ltd. · 2003
- Descendant · cites it directly · 12 of its ownK040591 Duet SystemBioview, Ltd. · 2004
- Descendant · 2 generations on · 7 of its ownK050840 Modification to Duet SystemBioview, Ltd. · 2005
- Descendant · 2 generations on · 5 of its ownK061602 Duet SystemBioview, Ltd. · 2007
- Descendant · cites it directly · 4 of its ownK050236 FishviewApplied Spectral Imaging, Ltd. · 2005
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K030192Duet SystemBioview, Ltd. · 2003 · cites it directly13descendants
- K040591Duet SystemBioview, Ltd. · 2004 · cites it directly12descendants
- K050840Modification to Duet SystemBioview, Ltd. · 2005 · 2 generations on7descendants
- K061602Duet SystemBioview, Ltd. · 2007 · 2 generations on5descendants
- K050236FishviewApplied Spectral Imaging, Ltd. · 2005 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K902311 | Genevision - Computer Assisted Chromosome Karyo. | Applied Imaging Corp. | 1990 | — |
| 0 (this device) | K012103 | Bandview System | Applied Spectral Imaging, Ltd. | 2001 | — |
| +1 | K030192 | Duet System | Bioview, Ltd. | 2003 | — |
| +1 | K040591 | Duet System | Bioview, Ltd. | 2004 | — |
| +2 | K050840 | Modification to Duet System | Bioview, Ltd. | 2005 | — |
| +2 | K061602 | Duet System | Bioview, Ltd. | 2007 | — |
| +1 | K050236 | Fishview | Applied Spectral Imaging, Ltd. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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 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? (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 |
|---|---|---|---|
| * | K940240 | IkarosSummary page 2…Regulation No. 864.5260) and they are reviewed by the Pathology Panel. 7-3 Predicate Device: ¢ Ikaros, manufactured by MetaSystems GmbH, cleared under K940240. ¢ Genevision, manufactured by Applied Imaging Corp. cleared under K902311. Performance Standards: No performance standards ha… | 1995 |
| * | K902311 | Genevision - Computer Assisted Chromosome Karyo.Summary page 2…3 Predicate Device: ¢ Ikaros, manufactured by MetaSystems GmbH, cleared under K940240. ¢ Genevision, manufactured by Applied Imaging Corp. cleared under K902311. Performance Standards: No performance standards have been established for such device under Section 514 of the Federal Food, D… | 1990 |
What descends from it? (14)
See all 143 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?
- None of the 2 ancestors has a recall.
- Of its descendants, K030192 (Bioview, Ltd., 2003) has gone furthest, with 13 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 | — |
What is it indicated for?
The BandView system is intended to be used for karyotyping with real-time microscope images from cultured and stained cell specimens in their metaphase. The system works with brght field and fluorescent samples with all currently applied banding techniques including G-banding and DAPI-banding. All specimens suitable for banding analysis including from amniotic fluid, peripheral blood, chorionic willus, bone marrow, and tissue can be used without…
Read the full statement (137 words)
The BandView system is intended to be used for karyotyping
with real-time microscope images from cultured and stained cell
specimens in their metaphase. The system works with brght
field and fluorescent samples with all currently applied banding
techniques including G-banding and DAPI-banding. All
specimens suitable for banding analysis including from amniotic
fluid, peripheral blood, chorionic willus, bone marrow, and tissue
can be used without limitation to specific diseases. Karyotyping
is normally applied for the pre and postnatal diagnosis of birth
defects, chromosome abnormalities, genetic diseases (such as
Down's syndrome), cancer, and for the follow up of cancer
treatment.
The BandView system does not locate metaphase spreads; it
does not rank the given cells according to quality; it does not
automatically classify chromosomes; it does require and relies
completely on the operator to manipulate the digitized
MICToSCope 1mages.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012103 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012103: Bandview System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012103
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026