510(k) K242783

Device
Roche Digital Pathology Dx
Applicant
Ventana Medical Systems, Inc.
510(k) number
K242783
Product code
PSY
Decision
Substantially Equivalent (SESE)
Decision date
2024-12-17
Date received
2024-09-16
Regulation
864.3700
Classification name
Whole Slide Imaging System
Medical specialty
Pathology
Review panel
Pathology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Cameron Smith
Address
(Ventana, Vmsi, Roche Tissue Diagnostics, Rtd) 1910 E. Innovation Park Dr. Tucson AZ US 85755 85755

FDA Registration Numbers

Source Documents

510(k) summary PDF

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