Roche Digital Pathology Dx
FDA 510(k) K242783 · Ventana Medical Systems, Inc.
510(k) numberK242783
Submission
- Device name
- Roche Digital Pathology Dx
- Applicant
- Ventana Medical Systems, Inc.
Tucson, AZ, US - Received
- September 16, 2024
- Decision date
- December 17, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| 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 |
| K232879 | Roche Digital Pathology Dx (VENTANA DP 200)PSY · Traditional | Ventana Medical Systems, Inc. | 06/14/2024SE |
More from Ventana Medical Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K232879 | Roche Digital Pathology Dx (VENTANA DP 200)PSY · Traditional | 06/14/2024SE |
| K212176 | CINtec HistologyPRB · Traditional | 12/10/2021SE |
| K172471 | VENTANA CD30 (Ber-H2) RxDx AssayDEH · Traditional | 05/08/2018SE |
| K142965 | Virtuoso System for IHC PR (1E2) using iScan HTOEO · Traditional | 07/16/2015SE |
| K140465 | Virtuoso System for Ihc Er (SP1) with Benchmark Ultra StainerNQN · Traditional | 03/20/2014SE |
| K130515 | Virtuoso System for Ihc Er (Spi)NQN · Traditional | 11/22/2013SE |
| K121516 | Virtuoso System for Ihc HER2 (4B5)NQN · Traditional | 09/26/2013SE |
| K122143 | Virtuoso System for Ihc PR (1E2) Benchmark Ultra StainerNQN · Traditional | 09/19/2013SE |
| K121033 | Virtuoso System for Ihc KI-67 (30-9)NOT · Traditional | 09/06/2013SE |
| K110215 | Confirm Anti-Estrogen Receptor (SP1) Rabbit Monoclonal Primary AntibodyMYA · Traditional | 12/17/2012SE |
Questions and answers
When was Roche Digital Pathology Dx cleared by the FDA?
Roche Digital Pathology Dx (K242783) received a 510(k) decision of Substantially Equivalent on December 17, 2024, 92 days after the submission was received.
What is the product code of K242783?
The FDA product code is PSY – Whole Slide Imaging System, a Class II (moderate risk) device regulated under 21 CFR 864.3700.