FDA 510(k)

Roche Digital Pathology Dx

K-Number: K242783 · 2024-12-17

Decision Date2024-12-17

Product CodePSY

Advisory CommitteePA

DecisionSubstantially Equivalent

Device Summary

Roche Digital Pathology Dx is the device name listed in this FDA 510(k) record. The listed applicant is Ventana Medical Systems, Inc.. It received FDA 510(k) clearance on 2024-12-17 under 510(k) 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. The listed applicant is Ventana Medical Systems, Inc.. The 510(k) number is K242783.

When did Roche Digital Pathology Dx receive FDA 510(k) clearance?

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

Who is the listed applicant for Roche Digital Pathology Dx?

The FDA 510(k) record lists Ventana Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Ventana Medical Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P990081SYSTEM, TEST, HER-2/NEU, IHC PMA P190031Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer PMA P200019Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay PMA P190024Immunocytochemistry assay, p16/Ki-67 PMA P230018Immunohistochemistry assay, antibody, claudin 18 PMA P220006Immunohistochemistry Assay, Antibody, FOLR1

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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.