Medical imaging and radiology
Aidoc
Clinical AI platform for radiology and enterprise imaging workflows.
Last updated: June 5, 2026
Back to directoryFujifilm CAD EYE medical AI product profile
Fujifilm AI-powered endoscopic imaging technology that supports real-time colonic polyp detection in compatible endoscopy workflows.
Medical imaging and radiology
Best fit
Endoscopy programs already evaluating or using Fujifilm ELUXEO infrastructure and comparing FDA-cleared AI detection support for colonoscopy.
- Primary use case
- AI-assisted real-time detection of colonic mucosal lesions during colonoscopy with Fujifilm endoscopy systems
- Audience
- Endoscopy units, gastroenterology groups, hospitals using Fujifilm ELUXEO systems, and GI technology governance teams
- Risk level
- High
- Pricing signal
- Enterprise endoscopy-system pricing; verify current ELUXEO compatibility, module availability, installation, service, and support terms.
- Official sources
- 4 official sources
Compare within workflow: Medical imaging and radiology · comparison shortlist · source index
Regulatory, privacy, evidence, and workflow lens
Product-specific review. These product-specific signals summarize what the cited sources imply before treating Fujifilm CAD EYE as safe for a local clinical, operational, or research workflow.
| Regulatory / FDA | Match CAD EYE, EW10-EC02, SCALE EYE, and any characterization feature to the exact FDA record, indication, hardware configuration, and market availability because they should not be treated as one blanket authorization. |
|---|---|
| Privacy | Review whether endoscopy images, video, metadata, support diagnostics, service access, and software-update logs stay on local equipment or move through vendor-managed systems. |
| Evidence | Validate clinical evidence for the local colonoscopy population, endoscope hardware, lesion size and morphology, false markers, missed lesions, and effect on procedure quality metrics. |
| Workflow | Best governed as physician-reviewed detection support inside a compatible Fujifilm room, with explicit training, equipment checks, documentation rules, and post-live quality monitoring. |
Where Fujifilm CAD EYE fits
Fujifilm describes CAD EYE as AI deep-learning technology for real-time detection of colonic mucosal lesions during colonoscopy; Fujifilm announced U.S. 510(k) clearance and commercialization for CAD EYE, while FDA summary materials identify EW10-EC02 as gastrointestinal lesion software detection support for colonoscopic images.
Not for: Standalone diagnosis, unsupported endoscope systems, treatment decisions without physician interpretation, or assuming detection, sizing, and characterization features share one clearance.
What to verify before using Fujifilm CAD EYE
- FDA 510(k) status for the exact CAD EYE or EW10-EC02 software version, intended use, compatible Fujifilm hardware, and current U.S. availability.
- Whether the planned room uses validated ELUXEO processors, colonoscopes, displays, network configuration, and software versions.
- How detection output, any sizing or characterization features, and final clinical decisions are separated in reports and quality review.
- Local impact on adenoma detection, false-positive markers, lesion miss rate, workflow time, training needs, and endoscopist override behavior.
Source links
Use these links to confirm current claims, terms, regulatory status, pricing, and deployment requirements.
- healthcaresolutions-us.fujifilm.com / products / endoscopy
- www.fujifilm.com / us / en
- www.fujifilm.com / us / en
- www.accessdata.fda.gov / cdrh_docs / pdf23
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