510(k) · Cleared
ClearedGenasis Scanview 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 Feb 7, 2013 as substantially equivalent to K110345 (Applied Spectral Imaging, 2011) after a 170-day review. Its family tree reaches back 8 generations to 1993.
- Decided
- Feb 7, 2013
- Review
- 170 days
- Class
- Class II
- Product code
- NTH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K925670 (1993). 19 ancestors in all, the oldest K902311 (1990). No later device cites it as a predicate yet.
- Root · 8 generations backK925670 IMS-200Intelligent Medica Imaging, Inc. · 1993
- 7 generations backK984188 Automated Cellular Imaging System (Acis)Chroma Vision Medical Systems, Inc. · 1999
- 6 generations backK030192 Duet SystemBioview, Ltd. · 2003
- 5 generations backK040591 Duet SystemBioview, Ltd. · 2004
- 4 generations backK050840 Modification to Duet SystemBioview, Ltd. · 2005
- 3 generations backK061602 Duet SystemBioview, Ltd. · 2007
- 2 generations backK101291 Scanview HER2/Neu Fish SystemApplied Spectral Imaging, Ltd. · 2010
- 1 generation backK110345 Scanview SystemApplied Spectral Imaging · 2011
- This deviceK122554 Genasis Scanview SystemApplied Spectral Imaging, Ltd. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K925670 | IMS-200 | Intelligent Medica Imaging, Inc. | 1993 | — |
| −7 | K984188 | Automated Cellular Imaging System (Acis) | Chroma Vision Medical Systems, Inc. | 1999 | — |
| −6 | K030192 | Duet System | Bioview, Ltd. | 2003 | — |
| −5 | K040591 | Duet System | Bioview, Ltd. | 2004 | — |
| −4 | K050840 | Modification to Duet System | Bioview, Ltd. | 2005 | — |
| −3 | K061602 | Duet System | Bioview, Ltd. | 2007 | — |
| −2 | K101291 | Scanview HER2/Neu Fish System | Applied Spectral Imaging, Ltd. | 2010 | — |
| −1 | K110345 | Scanview System | Applied Spectral Imaging | 2011 | — |
| 0 (this device) | 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 |
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? (1)
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 |
|---|---|---|---|
| * | K110345 | Scanview SystemSummary page 3…icate device: parameter GenASls ScanView System ScanView System I 510(k) K122554 K110345 number 2 Owner Applied Spectral lImaging Ltd. Applied Spectral Imaging Ltd. 3 Intended… | 2011 |
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 20 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- 3 of the 19 ancestors have a recall of any class.
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. 2013, 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 GenASis 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 GenASIs ScanView System is indicated as an accessory to the following FDA cleared/approved devices to detect the following cell types: 1. CEP®…
Read the full statement (412 words)
The GenASis 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 GenASIs ScanView System is indicated as an accessory to the following FDA cleared/approved devices to detect the following cell types:
1. CEP® X Spectrum Orange TM/CEPS Y Spectrum Greenm DNA Probe Kit and is limited to the analysis of CEP XY probes via high magnification capture and analysis of interphase 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 Vysion T 'HER-2 DNA Probe kit. Results from 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 Tm 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 UroVysion Tm Bladder Cancer Kit to detect aneuploidy for chromosomes 3, 7, 17, and loss of the 9p2l locus, from persons with hematuria 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 hematuria and subsequent monitoring for tumor recurrence in patients previously diagnosed with bladder cancer.
4. Gene rearrangements involving the ALK gene (2 p2 3 ) via fluorescence in situ hybridization (FISH) in formalin-fixed paraffin-embedded (FEPE) non-small cell lung cancer (NSCLC) tissue specimens, using Vysisg ALK (Anaplastic Lymphoma Kinase) Break Apart FISH Probe kit. The Vysis ALK Break Apart FISH Probe Kit is indicated to aid in identifying those patients eligible for treatment with XALKORI@ (crizotinib). The GenASIs ALK System is an accessory to Vysis® ALK (Anaplastic Lymphoma Kinase) Break Apart FISH Probe kit.
The GenASIs 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/K122554 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122554: Genasis 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/K122554
Report an extraction error
Are you the manufacturer?
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