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: CEP® X Spectrum Orange™/CEP® Y Spectrum Green™ DNA Probe kit (Abbott Laboratories, Illinois, U.S.A) 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 the Vysion™ HER-2 DNA Probe kit. The ScanView System is to be used as an adjunctive automated enumeration tool in conjunction with manual visualization.
Device Story
ScanView is an integrated digital imaging system comprising a motorized microscope, multi-slide stage, camera, and workstation. It acquires brightfield and fluorescent images of cells; enables identification, examination, enhancement, archiving, and printing of cell images. Operated by pathologists or cytogeneticists in clinical settings, the system automates Z-axis focus and X-Y stage movement. It functions as an adjunctive tool for automated enumeration of cells based on color, intensity, size, pattern, and shape. By automating the scanning and analysis of interphase nuclei, it assists clinicians in detecting specific genetic markers (CEP XY, HER-2/neu), thereby supporting clinical decision-making regarding bone marrow transplant effectiveness and breast cancer diagnosis. The system provides automated enumeration while requiring manual visualization for final verification.
Clinical Evidence
Bench testing only. Method comparison study at three clinical sites (n=126 slides) compared ScanView HER-2 FISH System to manual method. Total agreement 98.4% (95% CI: 96%-100%). Negative agreement (<1.8) 100%; borderline agreement (1.8-2.2) 88.9%; positive agreement (>2.2) 100%. Precision/reproducibility evaluated using 6-slide panel across sites/days; CVs reported as acceptable.
Technological Characteristics
Integrated digital imaging system including external microscope, motorized multi-slide stage, camera, and workstation. Features motorized filter turret for fluorescence. Supports brightfield and fluorescent illumination. Software-based image analysis for cell detection, classification, and enumeration.
Indications for Use
Indicated for pathologists/cytogeneticists to detect, classify, and enumerate cells in: 1) Bone marrow transplant patients (CEP XY probes) to assess transplant effectiveness; 2) Formalin-fixed, paraffin-embedded human breast cancer tissue specimens (HER-2/neu gene and chromosome 17 centromere) using Vysis PathVysion HER-2 DNA Probe kit.
Regulatory Classification
Identification
An automated FISH enumeration system is a device that consists of an automated scanning microscope, image analysis system, and customized software applications for FISH assays. This device is intended for in vitro diagnostic use with FISH assays as an aid in the detection, counting and classification of cells based on recognition of cellular color, size, and shape, and in the detection and enumeration of FISH signals in interphase nuclei of formalin-fixed, paraffin-embedded human tissue specimens.
Special Controls
The device is classified as Class II under regulation 21 CFR 866.4700 with special controls. The special control guidance document " Class II Special Controls Guidance Document: Automated Fluorescence in situ Hybridization (FISH) Enumeration Systems" is available at www.fda.gov/cdrh/oivd/guidance/1550.pdf.
*Classification.* Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Automated Fluorescence*in situ* Hybridization (FISH) Enumeration Systems.” See § 866.1(e) for the availability of this guidance document.
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
A. 510(k) Number:
k101291
B. Purpose for Submission:
Addition to the ScanView System of fluorescence in situ hybridization (FISH) enumeration of the HER-2/neu gene for human breast cancer specimens
C. Manufacturer and Instrument Name:
Applied Spectral Imaging, Ltd., ScanView System
D. Type of Test or Tests Performed:
Automated fluorescence in situ hybridization (FISH) enumeration of the HER-2/neu gene in human breast cancer specimens (Vysis® PathVysion™ HER-2 DNA Probe kit).
E. System Descriptions:
1. Device Description:
The ScanView is an integrated digital imaging system constructed of an external microscope, motorized multi slide stage, camera, and a workstation. It is designed to acquire images of cells and enables identification and examination of cells of interest. Pathologists can view and scan cells and record the image, using both bright field and fluorescent illumination. The acquired images can be enhanced, archived, retrieved and printed. The automated microscope enables Z motion of the slide and the motorized stage enables its X-Y motions. The microscope also included motorized filter turret containing fluorescence filters.
2. Principles of Operation:
The ScanView system works with fluorescence in situ hybridization (FISH) stained human breast cancer tissue specimens by the Vysis® PathVysion™ HER-2 DNA Probe kit. The user defines the regions containing tumor cells and manually captures cells from these regions. The system automatically defines the cells of interest and the pathologist then either chooses specific cells for analysis or the system analyzes all of the cells from the selected regions. The red and green signals and the ratio for each cell alone with the average amplification level are calculated. The data are then presented to the pathologist for review. Each cell is displayed in a gallery and the pathologist can reject any one of the cells or modify its classification. The overall statistics are updated accordingly and only at the end of this process, after the pathologist confirms the final score, is the calculated amplification level printed out in a final report.
3. Modes of Operation:
Semi-automated; manual capture with computer-assisted interpretation
4. Specimen Identification:
Manual keyboard entry into a Case Data Manager.
5. Specimen Sampling and Handling:
Specimens are formalin-fixed paraffin embedded human breast cancer tissues hybridized with the Vysis® PathVysion™ HER-2 DNA Probe Kit.
6. Calibration:
Calibration is performed at the time of installation.
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7. Quality Control:
Control slides are prepared and run concurrently with patient slides according to the Vysis® PathVysion™ HER-2 DNA Probe kit Instructions. The control slides are tested on the ScanView System according to the same procedure as patient slides. It is the responsibility of the pathologist to make assure the control slides meet quality acceptance criteria.
8. Software:
FDA has reviewed applicant’s Hazard Analysis and Software Development processes for this line of product types:
Yes ☐ X or No ☐
F. Regulatory Information:
1. Regulation section:
866.4700, Automated fluorescence in situ hybridization (FISH) enumeration systems
2. Classification:
Class II
3. Product code:
NTH, system, automated scanning microscope and image analysis for fluorescence in situ hybridization (FISH) assays
4. Panel:
Immunology (82)
G. Intended Use:
1. Indication(s) for Use:
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. CEP® X Spectrum Orange™/CEP® Y Spectrum Green™ DNA Probe kit (Abbott Laboratories, Illinois, U.S.A.) 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® PathVysion™ HER-2 DNA Probe kit.
The Scan View System is to be used as an adjunctive automated enumeration tool in conjunction with manual visualization.
2. Special Conditions for Use Statement(s):
For Prescription Use Only.
H. Substantial Equivalence Information:
1. Predicate Device Name(s) and 510(k) numbers:
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BioView Ltd., Duet System, K061602
Applied Spectral Imaging, ScanView System, K071398
2. Comparison with Predicate Device:
| Similarities | | | |
| --- | --- | --- | --- |
| Item | Device ScanView System | Predicates | |
| | | Duet System K061602 | ScanView System K071398 |
| Indications for Use | 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® PathVysion™ HER-2 DNA Probe kit. | 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® PathVysion™ Her-2 DNA Probe Kit. The Duet™ is to be used as an adjunctive enumeration tool, in conjunction with manual visualization, to assist in determining HER-2/neu gene to chromosome 17 signal ratio. | Not applicable. |
| Probe Kit | Vysis PathVysion® HER-2 DNA Probe Kit | Same | Not applicable. |
| Device Components | Automated microscope, PC, keyboard and control panel, color monitor, CCD Camera, and motorized stage | Same | Same |
| Spatial resolution | 1280 x 1024 | Not known | 1280 x 1024 |
| Detection Method | FISH | Same | Same |
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| Differences | | | |
| --- | --- | --- | --- |
| Item | Device | Predicates | |
| | | Duet System K061602 | ScanView System K071398 |
| Indications for Use | 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® PathVysion™ HER-2 DNA Probe kit. | Not applicable. | The ScanView is indicated to detect the following cell types: CEP® X Spectrum Orange™/CEP® Y Spectrum Green™ DNA Probe Kit (Vysis, Inc. Downer’s Grove, IL) 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. |
I. Special Control/Guidance Document Referenced (if applicable):
“Class II Special Controls Guidance Document: Automated Fluorescence in situ Hybridization (FISH) Enumeration Systems” 23 May 2005.
CLSI Guideline document EP9-A2: “Method Comparison and Bias Estimation Using Patient Samples: Approved Guideline-Second Edition”.
Guidance for Industry and FDA Staff: “Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests”; March 2007.
“Guidance for the Content of Premarket Submission for Software Contained in Medical Device”, CDRH, May 2005.
J. Performance Characteristics:
1. Analytical Performance:
a. Accuracy:
A method comparison study was conducted at three clinical sites: 47 slides from site 1, 34 slides from site 2, and 45 slides from site 3 for a total of 126 slides. Measurements of the 126 slides using results obtained from the Scan View HER-2 FISH System were compared to the manual method.
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Summary of Results (ScanView System versus Manual Method)
| | Manual Method | | | |
| --- | --- | --- | --- | --- |
| | | <1.8 | 1.8 to 2.2 | >2.2 |
| ScanView Method | <1.8 | 74 | 2 | 0 |
| | 1.8 to 2.2 | 0 | 16 | 0 |
| | >2.2 | 0 | 0 | 34 |
Total agreement was 98.4% (124/126) with 95% CI (96%-100%). Negative (<1.8) percent agreement was 100% (74/74) with 95% CI (99%-100%, borderline (1.8-2.2) percent agreement was 88.9% (16/18) with 95% CI (74%-100%) and positive (>2.2) percent agreement was 100% (34/34) with 95% CI (97%-100%).
b. Precision/Reproducibility:
A panel of 6 slides: 2 negative (<1.8), 2 borderline (1.8-2.2), and 2 positive (>2.2), was used to access precision and reproducibility. Three replicates for each slide were tested for within day/within instrument and between day precision and between instrument (site-to-site) reproducibility. Coefficients of Variation (CVs) were acceptable. The results are presented below:
| Slide No | Manual | Within day/within instrument | | | Between instruments | | | Between day | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | Mean | CV | Std Dev | Mean | CV | Std Dev | Mean | CV | Std Dev |
| 1 | 2.02 | 1.93 | 0.04 | 0.076 | 1.99 | 0.03 | 0.059 | 1.96 | 0.008 | 0.015 |
| 2 | 2.10 | 1.95 | 0.066 | 0.129 | 2.03 | 0.018 | 0.036 | 1.98 | 0.023 | 0.046 |
| 3 | 1.27 | 1.13 | 0.102 | 0.115 | 1.20 | 0.046 | 0.055 | 1.16 | 0.022 | 0.026 |
| 4 | 1.38 | 1.09 | 0.16 | 0.182 | 1.16 | 0.036 | 0.042 | 1.16 | 0.015 | 0.017 |
| 5 | 5.70 | 5.82 | 0.049 | 0.285 | 5.95 | 0.01 | 0.062 | 5.92 | 0.025 | 0.149 |
| 6 | 4.10 | 4.23 | 0.07 | 0.295 | 4.12 | 0.026 | 0.107 | 4.20 | 0.045 | 0.191 |
c. Linearity:
Not applicable.
d. Carryover:
Not applicable.
e. Interfering Substances:
Not applicable.
2. Other Supportive Instrument Performance Data Not Covered Above:
Not applicable
K. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
L. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
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Learn the FDA Browser
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
