Hamamatsu Photonics K.K.: FDA clearances and approvals
Hamamatsu Photonics K.K. has 10 FDA 510(k) clearances (first 1989, latest 2026), across 6 product codes in 3 review panels. Median 510(k) review time: 116 days. Since 2017 its median was 180 days, against 88 days for all cleared 510(k)s in the same product codes. It is the industry lead sponsor of 1 device clinical trial on ClinicalTrials.gov.
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, Hamamatsu Photonics K.K.'s cleared 510(k)s 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 company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Hamamatsu Photonics K.K. is the industry 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 does Hamamatsu Photonics K.K. have?
Hamamatsu Photonics K.K. has 10 FDA 510(k) clearances (first 1989, latest 2026), across 6 product codes in 3 review panels.
How long does FDA take to clear Hamamatsu Photonics K.K.'s 510(k)s?
The median time from FDA receipt to decision across Hamamatsu Photonics K.K.'s cleared 510(k)s is 116 days. Since 2017: 180 days, versus 88 days for all cleared 510(k)s in the same product codes.
What devices does Hamamatsu Photonics K.K. make?
Its most frequent FDA product codes are PSY (Whole Slide Imaging System, 4); MUD (Oximeter, Tissue Saturation, 2); IZI (System, X-Ray, Angiographic, 1).
Has Hamamatsu Photonics K.K. had device recalls?
openFDA lists no recalls under a recalling firm name matching Hamamatsu Photonics K.K. Related entities may recall under other names.
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. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.