NanoZoomer S540MD Slide Scanner System
FDA 510(k) K260964 · Hamamatsu Photonics K.K.
510(k) numberK260964
Submission
- Device name
- NanoZoomer S540MD Slide Scanner System
- Applicant
- Hamamatsu Photonics K.K.
Hamamatsu City, JP - Received
- March 23, 2026
- Decision date
- July 22, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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 |
| 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 |
| 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 |
|---|---|---|
| K253606 | NanoZoomer S20MD Slide scanner system; NanoZoomer S360MD Slide scanner systemPSY · Abbreviated | 07/15/2026SE |
| K233027 | NanoZoomer S360MD Slide scanner systemPSY · Abbreviated | 12/22/2023SE |
| K213883 | NanoZoomer S360MD Slide scanner systemPSY · Traditional | 09/27/2022SE |
| K162117 | NIRO-200NX DPMUD · Traditional | 10/25/2016SE |
| K143219 | NIRO-200NXMUD · Traditional | 07/31/2015SE |
| K133719 | Pde-NeoIZI · Traditional | 03/27/2014SE |
| K110480 | Pde Photodynamic EyeOWN · Traditional | 01/13/2012SE |
| K982171 | Hamamatsu PET Scanner, Model SHR-22000KPS · Traditional | 09/17/1998SE |
| K896331 | V2465P X-Ray Image IntensifierJAA · Traditional | 12/22/1989SE |
Questions and answers
When was NanoZoomer S540MD Slide Scanner System cleared by the FDA?
NanoZoomer S540MD Slide Scanner System (K260964) received a 510(k) decision of Substantially Equivalent on July 22, 2026, 121 days after the submission was received.
What is the product code of K260964?
The FDA product code is PSY – Whole Slide Imaging System, a Class II (moderate risk) device regulated under 21 CFR 864.3700.