# Hamamatsu Photonics K.K.

- Location (FDA's records): Hamamatsu City, JP
- FDA decisions: 10 (1989–2026): 10 510(k) clearances
- Product codes: PSY (4), MUD (2), IZI (1), KPS (1), JAA (1), OWN (1)
- 510(k) review time since 2016: median 121 days, against 253 for FDA's reviews in the same codes and years (3 of 3 faster)
- Predicates its devices cite: 12 (5 its own); citations of its devices by later devices: 18 (5 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Novadaq Technologies, Inc.: 2 (https://510kreport.com/company/novadaq-technologies)
- Cti Pet Systems, Inc.: 1 (https://510kreport.com/company/cti-pet-systems)
- Philips Medical Systems Nederland B.V.: 1 (https://510kreport.com/company/philips-medical-systems-nederland)
- Somanetics Corp.: 1 (https://510kreport.com/company/somanetics)
- Hitachi Medical Systems America, Inc.: 1 (https://510kreport.com/company/hitachi-medical-systems-america)
- Hitachi Medical Corp.: 1 (https://510kreport.com/company/hitachi-medical)

## Firms that cite its devices most
- Indica Labs, Inc.: 2 (https://510kreport.com/company/indica-labs)
- Paige.Ai, Inc.: 1 (https://510kreport.com/company/paige-ai)
- Pathpresenter Corporation: 1 (https://510kreport.com/company/pathpresenter)
- Infinitt Healthcare Co., Ltd.: 1 (https://510kreport.com/company/infinitt-healthcare)
- PathAI, Inc.: 1 (https://510kreport.com/company/pathai)
- Proscia, Inc.: 1 (https://510kreport.com/company/proscia)
- Quest Medical Imaging: 1 (https://510kreport.com/company/quest-medical-imaging)
- Tribun Health: 1 (https://510kreport.com/company/tribun-health)

## Its most-cited devices
- K233027: NanoZoomer S360MD Slide scanner system (2023), cited by 7
- K213883: NanoZoomer S360MD Slide scanner system (2022), cited by 6
- K133719: Pde-Neo (2014), cited by 2
- K110480: Pde Photodynamic Eye (2012), cited by 2
- K143219: Niro-200NX (2015), cited by 1

## Recent decisions
- K260964: NanoZoomer S540MD Slide Scanner System (Jul 22, 2026)
- K253606: NanoZoomer S20MD Slide scanner system; NanoZoomer S360MD Slide scanner system (Jul 15, 2026)
- K233027: NanoZoomer S360MD Slide scanner system (Dec 22, 2023)
- K213883: NanoZoomer S360MD Slide scanner system (Sep 27, 2022)
- K162117: Niro-200NX DP (Oct 25, 2016)
- K143219: Niro-200NX (Jul 31, 2015)
- K133719: Pde-Neo (Mar 27, 2014)
- K110480: Pde Photodynamic Eye (Jan 13, 2012)

Source page: https://510kreport.com/company/hamamatsu-photonics