Roche Digital Pathology Dx (VENTANA DP 200)
FDA 510(k) K232879 · Ventana Medical Systems, Inc.
510(k) numberK232879
Submission
- Device name
- Roche Digital Pathology Dx (VENTANA DP 200)
- Applicant
- Ventana Medical Systems, Inc.
Tucson, AZ, US - Received
- September 18, 2023
- Decision date
- June 14, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PSY – Whole Slide Imaging System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.3700
- Specialty
- Pathology
The whole slide imaging system is an automated digital slide creation, viewing, and management system intended as an aid to the pathologist to review and interpret digital images of surgical pathology slides prepared from formalin-fixed, paraffin-embedded (FFPE) tissue. The system generates digital images that would otherwise be appropriate for manual visualization by conventional brightfield…
Other 510(k)s with product code PSY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253554 | Aperio GT 450 DX; Aperio GT 180 DXPSY · Traditional | Leica Biosystems Imaging, Inc. | 08/07/2026SE |
| K260964 | NanoZoomer S540MD Slide Scanner SystemPSY · Abbreviated | Hamamatsu Photonics K.K. | 07/22/2026SE |
| K251952 | VirasightPSY · Traditional | Virasoft Corporation | 07/17/2026SE |
| K253606 | NanoZoomer S20MD Slide scanner system; NanoZoomer S360MD Slide scanner systemPSY · Abbreviated | Hamamatsu Photonics K.K. | 07/15/2026SE |
| K243871 | Philips IntelliSite Pathology Solution 5.1PSY · Traditional | Philips Medical Systems Nederland B.V. | 03/06/2025SE |
| K241717 | E1000 Dx Digital Pathology SolutionPSY · Traditional | Shandon Diagnostics Limited | 02/28/2025SE |
| K242783 | Roche Digital Pathology DxPSY · Special | Ventana Medical Systems, Inc. | 12/17/2024SE |
| K242848 | Philips IntelliSite Pathology Solution 5.1PSY · Traditional | Philips Medical Systems Nederland B.V. | 12/10/2024SE |
| K241871 | Philips IntelliSite Pathology SolutionPSY · Traditional | Philips Medical Systems Nederland B.V. | 12/02/2024SE |
| K233204 | Philips IntelliSite Pathology Solution 5.1PSY · Traditional | Philips Medical Systems Nederland B.V. | 06/24/2024SE |
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Questions and answers
When was Roche Digital Pathology Dx (VENTANA DP 200) cleared by the FDA?
Roche Digital Pathology Dx (VENTANA DP 200) (K232879) received a 510(k) decision of Substantially Equivalent on June 14, 2024, 270 days after the submission was received.
What is the product code of K232879?
The FDA product code is PSY – Whole Slide Imaging System, a Class II (moderate risk) device regulated under 21 CFR 864.3700.