510(k) · Cleared
ClearedFishview
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 Jun 27, 2005 as substantially equivalent to K012103 (Applied Spectral Imaging, Ltd., 2001) and 1 other predicate after a 147-day review. Its family tree reaches back 4 generations to 1993. 4 later devices descend from it.
- Decided
- Jun 27, 2005
- Review
- 147 days
- Class
- Class II
- Product code
- LNJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K925670 (1993). 8 ancestors in all, the oldest K902311 (1990). 4 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK925670 IMS-200Intelligent Medica Imaging, Inc. · 1993
- 3 generations backK984188 Automated Cellular Imaging System (Acis)Chroma Vision Medical Systems, Inc. · 1999
- 2 generations backK030192 Duet SystemBioview, Ltd. · 2003
- 1 generation backK040591 Duet SystemBioview, Ltd. · 2004
- This deviceK050236 FishviewApplied Spectral Imaging, Ltd. · 2005
- Descendant · cites it directly · 3 of its ownK071398 Scanview, Model SC-300Applied Spectral Imaging, Ltd. · 2007
- Descendant · 2 generations on · 2 of its ownK101291 Scanview HER2/Neu Fish SystemApplied Spectral Imaging, Ltd. · 2010
- Descendant · 3 generations on · 1 of its ownK110345 Scanview SystemApplied Spectral Imaging · 2011
- Descendant · 4 generations on · 0 of its ownK122554 Genasis Scanview SystemApplied Spectral Imaging, Ltd. · 2013
Most influential descendants
Showing 4 of 4 · See all- K071398Scanview, Model SC-300Applied Spectral Imaging, Ltd. · 2007 · cites it directly3descendants
- K101291Scanview HER2/Neu Fish SystemApplied Spectral Imaging, Ltd. · 2010 · 2 generations on2descendants
- K110345Scanview SystemApplied Spectral Imaging · 2011 · 3 generations on1descendant
- K122554Genasis Scanview SystemApplied Spectral Imaging, Ltd. · 2013 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K925670 | IMS-200 | Intelligent Medica Imaging, Inc. | 1993 | — |
| −3 | K984188 | Automated Cellular Imaging System (Acis) | Chroma Vision Medical Systems, Inc. | 1999 | — |
| −2 | K030192 | Duet System | Bioview, Ltd. | 2003 | — |
| −1 | K040591 | Duet System | Bioview, Ltd. | 2004 | — |
| 0 (this device) | K050236 | Fishview | Applied Spectral Imaging, Ltd. | 2005 | — |
| +1 | K071398 | Scanview, Model SC-300 | Applied Spectral Imaging, Ltd. | 2007 | — |
| +2 | K101291 | Scanview HER2/Neu Fish System | Applied Spectral Imaging, Ltd. | 2010 | — |
| +3 | K110345 | Scanview System | Applied Spectral Imaging | 2011 | — |
| +4 | K122554 | Genasis Scanview System | Applied Spectral Imaging, Ltd. | 2013 | — |
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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | K012103 | Bandview SystemSummary page 1…Class ILProduct Reason for 51O(k) Submission Traditional 510(k) Submission Identification of Legalvy Marketed Equivalent Devices BANDView system K012103 Duet system K040591, Device Description The FISHView is a modification of the legally marketed (K012103) BANDView syst… | 2001 |
| * | K040591 | Duet SystemSummary page 1…son for 51O(k) Submission Traditional 510(k) Submission Identification of Legalvy Marketed Equivalent Devices BANDView system K012103 Duet system K040591, Device Description The FISHView is a modification of the legally marketed (K012103) BANDView system. Digital visualizing, proce… | 2004 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071398 | Scanview, Model SC-300 | 2007 | 3 |
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 12 years and passes through 4 companies; a new generation was cleared every 4.1 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K071398 (Applied Spectral Imaging, Ltd., 2007) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K012103.
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 FISHView 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 bright field and fluorescent samples. Specimens suitable for banding analysis are: amniotic fluid, peripheral blood, chorionic villus, bone marrow and solid tumor. Karyotyping is normally applied for the pre and postnatal diagnosis of birth defects, chromosome abnormalities, genetic…
Read the full statement (167 words)
The FISHView 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 bright field and fluorescent samples. Specimens suitable for banding analysis are: amniotic fluid, peripheral blood, chorionic villus, bone marrow and solid tumor. 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 the cancer treatment. The FISHView system does not locate metaphase spreads; it does not rank the given cells according to quality; nor does it automatically classify chromosomes.
In addition the FISHView is intended as an aiding tool to the pathologist or cytogeneticist for digital visualizing, processing, counting and classification of stained cells and for storage of FISH multi-dye images of the following specimens: amniotic fluid, peripheral blood, chorionic villus, bone marrow and solid tumor.
The FISHView system does require and relies on the operator to analyze the digitized microscope images.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050236 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050236: Fishview.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050236
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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