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Applied Spectral Imaging Ltd

Israel IL-MF-000032463 Last updated 21 Oct 2026

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Devices
10
Registries
EUDAMEDFDA 510(k)GUDIDFDA
FDA recalls
0

Catalogue10

Authorised representatives

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • Applied Spectral Imaging IL

About

Shaping the Future of Digital Pathology and Cytogenetics Explore ASI’s Digital Cytogenetics Portfolio featuring Aided Karyotyping and Digital FISH Scanning and Analysis. Learn more Discover ASI’s Digital Pathology Portfolio Bridging the Gap between Brightfield and Fluorescence Whole Slide Imaging. Learn more Applied SpectralImaging Solution ASI’s comprehensive suite of computer-aided solutions for digital cytogenetics and pathology, \[…\]

From the manufacturer's own website. Source

What Applied Spectral Imaging Ltd makes

Applied Spectral Imaging Ltd manufactures digital pathology and cytogenetics systems, including fluorescence in situ hybridization (FISH) analysis tools like the FISHVIEW, SCANVIEW HER2/NEU FISH, and GENASIS SCANVIEW for automated slide scanning and imaging. Their portfolio also includes immunohistochemistry (IHC) analysis systems, such as the GENASIS HIPATH IHC family, designed for whole-slide fluorescence and brightfield imaging. Additional products like the BANDVIEW and SCANVIEW (Model SC-300) support digital cytogenetic analysis, while the RETINAL CUBE and ADI IVD System cater to retinal imaging and digital pathology workflows. Software solutions, including the ASI IVD System (versions 8.4 and HiPath IHCFamily), provide automated analysis and reporting for diagnostic applications.

The company’s devices are classified under EU Class A and Class II medical devices, with some falling under In Vitro Diagnostic (IVD) General regulations. They are registered in the EU’s eudamed database and listed in the FDA’s 510(k) clearance registry. Applied Spectral Imaging Ltd is based in Israel.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country
Israel
Address
2, Ha'Carmel Street, Yokneam, Israel
Phone
+972 4 6547567
PRRC contact
Ilan Sharon
EUDAMED SRN
IL-MF-000032463
DUNS number
600741763