Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hamamatsu Photonics K.K. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
121 daysmedian FDA review time
329 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260964 | NanoZoomer S540MD Slide Scanner System | Hamamatsu Photonics K.K. | 2026-07-22 | 121 | 0 |
| K253606 | NanoZoomer S20MD Slide scanner system; NanoZoomer S360MD Sli | Hamamatsu Photonics K.K. | 2026-07-15 | 239 | 0 |
| K233027 | NanoZoomer S360MD Slide scanner system | Hamamatsu Photonics K.K. | 2023-12-22 | 88 | 0 |
| K213883 | NanoZoomer S360MD Slide scanner system | Hamamatsu Photonics K.K. | 2022-09-27 | 288 | 1 |
| K162117 | NIRO-200NX DP | Hamamatsu Photonics K.K. | 2016-10-25 | 88 | 0 |
| K143219 | NIRO-200NX | Hamamatsu Photonics K.K. | 2015-07-31 | 263 | 0 |
| K133719 | PDE-NEO | Hamamatsu Photonics K.K. | 2014-03-27 | 112 | 0 |
| K110480 | PDE PHOTODYNAMIC EYE | Hamamatsu Photonics K.K. | 2012-01-13 | 329 | 0 |
| K982171 | HAMAMATSU PET SCANNER, MODEL SHR-22000 | Hamamatsu Photonics K.K. | 1998-09-17 | 90 | 0 |
| K896331 | V2465P X-RAY IMAGE INTENSIFIER | Hamamatsu Photonics K.K. | 1989-12-22 | 50 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda