Hamamatsu Photonics K.K.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Hamamatsu Photonics K.K.” (first 1989, latest 2026), across 6 product codes in 3 review panels. Median 510(k) review time under this name: 116 days. Since 2017 the median was 180 days, against 88 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 329 |
| 2013 | 0 | — |
| 2014 | 1 | 112 |
| 2015 | 1 | 263 |
| 2016 | 1 | 88 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 288 |
| 2023 | 1 | 88 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 2 | 180 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Hamamatsu Photonics K.K. took a median 180 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 88 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PSY | Whole Slide Imaging System | 4 | 4 |
| MUD | Oximeter, Tissue Saturation | 2 | 2 |
| IZI | System, X-Ray, Angiographic | 1 | 1 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 1 | 1 |
| KPS | System, Tomography, Computed, Emission | 1 | 1 |
| OWN | Confocal Optical Imaging | 1 | 1 |
Review panels
- Pathology (4)
- Radiology (3)
- General and Plastic Surgery (3)
Most recent Hamamatsu Photonics K.K. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260964 | NanoZoomer S540MD Slide Scanner System | PSY | 2026-07-22 | 121 |
| K253606 | NanoZoomer S20MD Slide scanner system; NanoZoomer S360MD Slide scanner system | PSY | 2026-07-15 | 239 |
| K233027 | NanoZoomer S360MD Slide scanner system | PSY | 2023-12-22 | 88 |
| K213883 | NanoZoomer S360MD Slide scanner system | PSY | 2022-09-27 | 288 |
| K162117 | NIRO-200NX DP | MUD | 2016-10-25 | 88 |
| K143219 | NIRO-200NX | MUD | 2015-07-31 | 263 |
| K133719 | PDE-NEO | IZI | 2014-03-27 | 112 |
| K110480 | PDE PHOTODYNAMIC EYE | OWN | 2012-01-13 | 329 |
| K982171 | HAMAMATSU PET SCANNER, MODEL SHR-22000 | KPS | 1998-09-17 | 90 |
| K896331 | V2465P X-RAY IMAGE INTENSIFIER | JAA | 1989-12-22 | 50 |
Recalls
openFDA lists no recalls under a recalling firm named Hamamatsu Photonics K.K..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Hamamatsu Photonics K.K. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT03992768: Feature Detection Study for Validation of Hamamatsu NanoZoomer S360MD Digital Slide Scanner System (Completed, started 2019-06-12)
Frequently asked questions
How many FDA 510(k) clearances are listed under Hamamatsu Photonics K.K.?
FDA lists 10 510(k) clearances under the applicant name “Hamamatsu Photonics K.K.” (first 1989, latest 2026), across 6 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Hamamatsu Photonics K.K.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hamamatsu Photonics K.K. is 116 days. Since 2017: 180 days, versus 88 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Hamamatsu Photonics K.K.?
The most frequent FDA product codes under this applicant name are PSY (Whole Slide Imaging System, 4); MUD (Oximeter, Tissue Saturation, 2); IZI (System, X-Ray, Angiographic, 1).
Next steps
- See all 10 Hamamatsu Photonics K.K. clearances with predicates and recalls
- Run predicate analysis for product code PSY, Hamamatsu Photonics K.K.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.