510(k) · Cleared
ClearedScanview HER2/Neu Fish System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Applied Spectral Imaging, Ltd. · NTH System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays
Cleared on Nov 23, 2010 as substantially equivalent to K071398 (Applied Spectral Imaging, Ltd., 2007) and 1 other predicate after a 200-day review. Its family tree reaches back 6 generations to 1993. 2 later devices descend from it.
- Decided
- Nov 23, 2010
- Review
- 200 days
- Class
- Class II
- Product code
- NTH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K925670 (1993). 17 ancestors in all, the oldest K902311 (1990). 2 later devices descend from it, 1 citing it directly.
- 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 deviceK101291 Scanview HER2/Neu Fish SystemApplied Spectral Imaging, Ltd. · 2010
- Descendant · cites it directly · 1 of its ownK110345 Scanview SystemApplied Spectral Imaging · 2011
- Descendant · 2 generations on · 0 of its ownK122554 Genasis Scanview SystemApplied Spectral Imaging, Ltd. · 2013
Most influential descendants
Showing 2 of 2 · See allView 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) | K101291 | Scanview HER2/Neu Fish System | Applied Spectral Imaging, Ltd. | 2010 | — |
| +1 | K110345 | Scanview System | Applied Spectral Imaging | 2011 | — |
| +2 | 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 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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? (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 |
|---|---|---|---|
| * | K071398 | Scanview, Model SC-300Summary page 1…lass II Reason for 510(k) Submission Traditional 510(k) Submission. Expansion of the indications for use. Identification of Legally Marketed Equivalent Devices ScanView K07 1398 Duet System K06 1602 Device Description The ScanView is an integrated digital imaging system constructed of an external… | 2007 |
| * | K061602 | Duet SystemSummary page 1…mission Traditional 510(k) Submission. Expansion of the indications for use. Identification of Legally Marketed Equivalent Devices ScanView K07 1398 Duet System K06 1602 Device Description The ScanView is an integrated digital imaging system constructed of an external microscope, motorized multi s… | 2007 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110345 | Scanview System | 2011 | 1 |
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 17 years and passes through 4 companies; a new generation was cleared every 3.8 years on median.
- 3 of the 17 ancestors have a recall of any class.
- Of its descendants, K110345 (Applied Spectral Imaging, 2011) has gone furthest, with 1 descendant of its own.
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. 2010, 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 ScanView System is an automated scanning microscope and image analysis system. It is intended for in-vitro diagnostic use as an aiding tool to the pathologist or cytogeneticist in the detection, classification and enumeration of cells of interest based on color, intensity, size, pattern, and shape. The ScanView is indicated to detect the following cell types: 1. CliP® X Spectrum Orangerm/CEP® Y Spectrum GreenTm DNA Probe kit (Abbott Laboratories…
Read the full statement (172 words)
The ScanView System is an automated scanning microscope and image analysis system. It is intended for in-vitro diagnostic use as an aiding tool to the pathologist or cytogeneticist in the detection, classification and enumeration of cells of interest based on color, intensity, size, pattern, and shape. The ScanView is indicated to detect the following cell types:
1. CliP® X Spectrum Orangerm/CEP® Y Spectrum GreenTm DNA Probe kit (Abbott Laboratories, Illinois, U.S.A) and is limited to the analysis of CEiP XY probes via high magnification capture and analysis of interphase nuclei. CEiP XY is indicated for use to assess the effectiveness of bone marrow transplantation in opposite-sex transplants
2. Human breast cancer containing the HER-2lneu gene labeled in Red and the centromere of chromosome 17 labeled in Green via fluorescence in situ hybridization (FISH) in interphase nuclei from formalin-fixed, paraffin embedded human breast cancer tissue specimens with the Vysis® Path VysionTM HER-2 DNA Probe kit.
The ScanView System is to be used as an adjunctive automated enumeration tool in conjunction with manual visualization.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101291 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101291: Scanview HER2/Neu Fish System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101291
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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