NanoZoomer S360MD Slide scanner system
FDA 510(k) K213883 · Hamamatsu Photonics K.K.
510(k) numberK213883
Submission
- Device name
- NanoZoomer S360MD Slide scanner system
- Applicant
- Hamamatsu Photonics K.K.
Hamamatsu City, JP - Received
- December 13, 2021
- Decision date
- September 27, 2022
- 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 |
More from Philips Medical Systems Nederland B.V.
| 510(k) | Device | Decision |
|---|---|---|
| K260964 | NanoZoomer S540MD Slide Scanner SystemPSY · Abbreviated | 07/22/2026SE |
| 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 |
| 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 S360MD Slide scanner system cleared by the FDA?
NanoZoomer S360MD Slide scanner system (K213883) received a 510(k) decision of Substantially Equivalent on September 27, 2022, 288 days after the submission was received.
What is the product code of K213883?
The FDA product code is PSY – Whole Slide Imaging System, a Class II (moderate risk) device regulated under 21 CFR 864.3700.