510(k) · Cleared
ClearedDuet System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bioview, Ltd. · NTH System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays
Cleared on May 9, 2014 as substantially equivalent to K030192 (Bioview, Ltd., 2003) and 3 other predicates after a 415-day review. Its family tree reaches back 6 generations to 1993.
- Decided
- May 9, 2014
- Review
- 415 days
- Class
- Class II
- Product code
- NTH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K925670 (1993). 14 ancestors in all, the oldest K902311 (1990). No later device cites it as a predicate yet.
- Root · 6 generations backK925670 IMS-200Intelligent Medica Imaging, Inc. · 1993
- 5 generations backK984188 Automated Cellular Imaging System (Acis)Chroma Vision Medical Systems, Inc. · 1999
- 4 generations backK030192 Duet SystemBioview, Ltd. · 2003
- 3 generations backK040591 Duet SystemBioview, Ltd. · 2004
- 2 generations backK050840 Modification to Duet SystemBioview, Ltd. · 2005
- 1 generation backK061602 Duet SystemBioview, Ltd. · 2007
- This deviceK130775 Duet SystemBioview, Ltd. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K925670 | IMS-200 | Intelligent Medica Imaging, Inc. | 1993 | — |
| −5 | K984188 | Automated Cellular Imaging System (Acis) | Chroma Vision Medical Systems, Inc. | 1999 | — |
| −4 | K030192 | Duet System | Bioview, Ltd. | 2003 | — |
| −3 | K040591 | Duet System | Bioview, Ltd. | 2004 | — |
| −2 | K050840 | Modification to Duet System | Bioview, Ltd. | 2005 | — |
| −1 | K061602 | Duet System | Bioview, Ltd. | 2007 | — |
| 0 (this device) | K130775 | Duet System | Bioview, Ltd. | 2014 | — |
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 |
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 NTH? 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? (5)
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…lassification Class 11 5.7 Panel Hematology and Immunology 5.8 Predicate Devices * DuetTM System, manufactured by BioView Ltd., cleared under k030192, k040591, k050840, and k061602. * Human manual visualization of formalin-fixed paraffin-embedded human lung… | 2003 |
| * | K040591 | Duet SystemSummary page 2…s 11 5.7 Panel Hematology and Immunology 5.8 Predicate Devices * DuetTM System, manufactured by BioView Ltd., cleared under k030192, k040591, k050840, and k061602. * Human manual visualization of formalin-fixed paraffin-embedded human lung cancer tissue s… | 2004 |
| * | K050840 | Modification to Duet SystemSummary page 2…7 Panel Hematology and Immunology 5.8 Predicate Devices * DuetTM System, manufactured by BioView Ltd., cleared under k030192, k040591, k050840, and k061602. * Human manual visualization of formalin-fixed paraffin-embedded human lung cancer tissue specimens,… | 2005 |
| * | K061602 | Duet SystemSummary page 2…Hematology and Immunology 5.8 Predicate Devices * DuetTM System, manufactured by BioView Ltd., cleared under k030192, k040591, k050840, and k061602. * Human manual visualization of formalin-fixed paraffin-embedded human lung cancer tissue specimens, probed by Vy… | 2007 |
| * | — | Human manual visualization of formalin-fixed paraffin-embedded human lung cancer tissue… Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
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 21 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
- 2 of the 14 ancestors have a recall of any class.
- 3 other devices also cite its predicate K030192.
How does its category compare?
All NTH devicesNTH System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · NTH
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · NTH
Too few NTH 510(k)s in any year since 2007 to give a median.
Recalls per year · NTH
No recall names NTH since 2007.
Adverse event reports per year · NTH
1in 2024
MAUDE reports naming product code NTH, 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 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 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 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 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 aid 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: 1. Detect Hematopoietic cells stained by Giemsa stain, Immunohistochemistry or ISH (with brightfield and fluorescent) prepared from cell suspension. 2.…
Read the full statement (257 words)
The DuetTM System is an automated scanning microscope and image analysis system. It is intended for in-vitro diagnostic use as an aid 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:
1. Detect Hematopoietic cells stained by Giemsa stain, Immunohistochemistry or ISH (with brightfield and fluorescent) prepared from cell suspension.
2. Detect Amniotic cells stained by FISH (using direct labeled DNA probes for chromosomes X,Y,13, 18 and 21).
3. Detect Aneuploidy for chromosomes 3,7, 17 and loss of the 9p21 locus via FISH in Urine specimens from subjects with transitional cell carcinoma of the bladder, probed by the Vysis Urovysion Bladder Cancer Kit.
4. Detect and quantify chromosome 17 and the HER-2/neu 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 review of the digital image, to assist in determining HER-2/neu gene to chromosome 17 signal ratio.
5. Qualitatively detect rearrangements involving the ALK gene via fluorescence in situ hybridization (FISH) in formalin-fixed paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) tissue specimens, probed with the Vysis® ALK Break Apart FISH Probe Kit. The DuetTM is to be used as an adjunctive automated enumeration tool, in conjunction with manual review of the digital image.
Note: The pathologist should verify the image analysis software application score.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130775 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130775: 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/K130775
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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