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FDA 510(k)

Roche Digital Pathology Dx

K-Number: K242783 · 2024-12-17

ApplicantVentana Medical Systems, Inc.
Decision Date2024-12-17
Product CodePSY
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

Roche Digital Pathology Dx is a medical device manufactured by Ventana Medical Systems, Inc.. It received FDA 510(k) clearance on 2024-12-17 under approval number K242783. The device is classified under product code PSY. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Roche Digital Pathology Dx?

Roche Digital Pathology Dx is a medical device that received FDA 510(k) clearance on 2024-12-17. It is manufactured by Ventana Medical Systems, Inc.. The 510(k) number is K242783.

When was Roche Digital Pathology Dx approved by the FDA?

Roche Digital Pathology Dx received FDA 510(k) clearance on 2024-12-17, under approval number K242783.

What company makes Roche Digital Pathology Dx?

Roche Digital Pathology Dx is manufactured by Ventana Medical Systems, Inc..

What is the FDA product code for Roche Digital Pathology Dx?

The FDA product code for Roche Digital Pathology Dx is PSY.

Related PubMed Literature

PMID: 41476571 Digital pathology imaging artificial intelligence in cancer research and clinical trials: An NCI workshop report. Journal of pathology informatics (2026) PMID: 41437380 Applications of artificial intelligence in non-small cell lung cancer: from precision diagnosis to personalized prognosis and therapy. Journal of translational medicine (2025)

Other Devices by Ventana Medical Systems, Inc.

DEN160019CINtec Histology (50 tests), CINtec Histology (250 tests) K172471VENTANA CD30 (Ber-H2) RxDx Assay K212176CINtec Histology DEN240025VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001) K232879Roche Digital Pathology Dx (VENTANA DP 200) PMA P160002Immunohistochemistry assay, antibody, programmed death-ligand 1

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Related Devices (Code: PSY)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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