Data / Medical devices / Japan / Hamamatsu Photonics K.K., Systems Division
Hamamatsu Photonics K.K., Systems Division: FDA-registered device maker in HAMAMATSU CITY Shizuoka, Japan, 7 510(k) clearances
Hamamatsu Photonics K.K., Systems Division is registered with the FDA (registration 9614683) in HAMAMATSU CITY Shizuoka, Japan. It lists 5 device types. The FDA files 7 510(k) clearances under its listings, the newest dated July 22, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9614683
- FEI number
- 3003794634
- Address
- 812 Joko-Cho Chuo-Ku, HAMAMATSU CITY Shizuoka, Japan, --
- Owner or operator
- HAMAMATSU PHOTONICS, K.K. (8031665)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- October 23, 2013
- Registered through
- 2027
- Brand names listed
- Agilent S540MD Slide Scanner System, NIRO-200NX, NanoZoomer S20MD Slide scanner system, NanoZoomer S360MD Slide scanner system, NanoZoomer S360MD Slide scanner system+ BARCO monitor, NanoZoomer S540MD Slide scanner system, PDE, PDE-GEN3
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Confocal Optical Imaging | OWN | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Oximeter | DQA | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Oximeter, Tissue Saturation | MUD | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| System, X-Ray, Angiographic | IZI | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Whole Slide Imaging System | PSY | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 22, 2026 | K260964 | NanoZoomer S540MD Slide Scanner System | PSY | Substantially Equivalent | Hamamatsu Photonics K.K. | accessdata.fda.gov |
| July 15, 2026 | K253606 | NanoZoomer S20MD Slide scanner system; NanoZoomer S360MD Slide scanner system | PSY | Substantially Equivalent | Hamamatsu Photonics K.K. | accessdata.fda.gov |
| December 22, 2023 | K233027 | NanoZoomer S360MD Slide scanner system | PSY | Substantially Equivalent | Hamamatsu Photonics K.K. | accessdata.fda.gov |
| September 27, 2022 | K213883 | NanoZoomer S360MD Slide scanner system | PSY | Substantially Equivalent | Hamamatsu Photonics K.K. | accessdata.fda.gov |
| July 31, 2015 | K143219 | NIRO-200NX | MUD | Substantially Equivalent | Hamamatsu Photonics K.K. | accessdata.fda.gov |
| March 27, 2014 | K133719 | PDE-NEO | IZI | Substantially Equivalent | Hamamatsu Photonics K.K. | accessdata.fda.gov |
| January 13, 2012 | K110480 | PDE PHOTODYNAMIC EYE | OWN | Substantially Equivalent | Hamamatsu Photonics K.K. | accessdata.fda.gov |
Compare with other makers
- All makers of Whole Slide Imaging System
- All makers of Oximeter
- All makers of Oximeter, Tissue Saturation
- All makers of System, X-Ray, Angiographic
- All makers of Confocal Optical Imaging
Updated July 22, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.