510(k) · Cleared
ClearedScanview System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Applied Spectral Imaging · NTH System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays
Cleared on Oct 19, 2011 as substantially equivalent to K101291 (Applied Spectral Imaging, Ltd., 2010) and 1 other predicate after a 257-day review. Its family tree reaches back 7 generations to 1993. 1 later device descends from it.
- Decided
- Oct 19, 2011
- Review
- 257 days
- Class
- Class II
- Product code
- NTH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K925670 (1993). 18 ancestors in all, the oldest K902311 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK925670 IMS-200Intelligent Medica Imaging, Inc. · 1993
- 6 generations backK984188 Automated Cellular Imaging System (Acis)Chroma Vision Medical Systems, Inc. · 1999
- 5 generations backK030192 Duet SystemBioview, Ltd. · 2003
- 4 generations backK040591 Duet SystemBioview, Ltd. · 2004
- 3 generations backK050840 Modification to Duet SystemBioview, Ltd. · 2005
- 2 generations backK061602 Duet SystemBioview, Ltd. · 2007
- 1 generation backK101291 Scanview HER2/Neu Fish SystemApplied Spectral Imaging, Ltd. · 2010
- This deviceK110345 Scanview SystemApplied Spectral Imaging · 2011
- Descendant · cites it directly · 0 of its ownK122554 Genasis Scanview SystemApplied Spectral Imaging, Ltd. · 2013
Most influential descendants
Showing 1 of 1 · See all- K122554Genasis Scanview SystemApplied Spectral Imaging, Ltd. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K925670 | IMS-200 | Intelligent Medica Imaging, Inc. | 1993 | — |
| −6 | K984188 | Automated Cellular Imaging System (Acis) | Chroma Vision Medical Systems, Inc. | 1999 | — |
| −5 | K030192 | Duet System | Bioview, Ltd. | 2003 | — |
| −4 | K040591 | Duet System | Bioview, Ltd. | 2004 | — |
| −3 | K050840 | Modification to Duet System | Bioview, Ltd. | 2005 | — |
| −2 | K061602 | Duet System | Bioview, Ltd. | 2007 | — |
| −1 | K101291 | Scanview HER2/Neu Fish System | Applied Spectral Imaging, Ltd. | 2010 | — |
| 0 (this device) | K110345 | Scanview System | Applied Spectral Imaging | 2011 | — |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K101291 | Scanview HER2/Neu Fish SystemSummary page 1…for 510(k) Submission Traditional 5 10(k). Expansion of the indications for use, by adding Bladder Tests. Identification of Legally Marketed Equivalent Devices ScanView k10 1291 Duet System k050840 Device Description The ScanView is an integrated digital imaging system constructed of an external microscope… | 2010 |
| * | K050840 | Modification to Duet SystemSummary page 1…n Traditional 5 10(k). Expansion of the indications for use, by adding Bladder Tests. Identification of Legally Marketed Equivalent Devices ScanView k10 1291 Duet System k050840 Device Description The ScanView is an integrated digital imaging system constructed of an external microscope. motorized multi sl… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122554 | Genasis Scanview System | 2013 | 0 |
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 18 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- 3 of the 18 ancestors have a recall of any class.
- Of its descendants, K122554 (Applied Spectral Imaging, Ltd., 2013) has gone furthest, with 0 descendants 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. 2011, 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 as anl accessory to the following FDA cleared/approved devices to detect the following cell types: 1. CEP® X Spectrum…
Read the full statement (326 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 as anl accessory to the following FDA cleared/approved devices to detect the following cell types:
1. CEP® X Spectrum OrangeiM/CEP® Y Spectrum GreenTM' DNA Probe Kit and is limited to the analysis of CEP XY probes via high magnification capture and analysis of inrerphase nuclei. CEP XY is indicated for use to assess the effectiveness of bone marrow transplantation in opposite-sex transplants.
2. Human breast cancer containing the HER-2/neu 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 Vysis® Path VysionTm HER-2 DNA Probe kit. Results f'rom the PathVysionM Kit are intended for use as an adjunct to existing clinical and pathologic information used as prognostic factors in stage 11, node-positive breast cancer patients. The Path Vysion T'" kit is further indicated as an aid to predict disease-free and overall survival in patients with stage 11, node positive breast cancer, treated with adjuvant cyclophosphamide, doxorubicin, and 5-fluorouracil (CAF) chemotherapy.
3. Cells in urine specimens, stained by fluorescence in situ hybridization (FISH) using Vysis UroVysionM Bladder Cancer Kit to detect aneuploidy for chromosomes 3, 7, 17, and loss of the 9p2I locus, from persons with hemnaturia suspected of having bladder cancer. The results are intended for use, in conjunction with and not in lieu of current standard diagnostic procedures, as an aid for initial diagnosis of bladder carcinoma in patients with hemnaturia and subsequent monitoring for tumor recurrence in patients previously diagnosed with bladder cancer.
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/K110345 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110345: Scanview System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110345
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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