Medical Device Manufacturer · US , Bridgewater , NJ

Hamamatsu Photonics K.K. - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 1989

Total

Cleared

Denied

FDA 510(k) Regulatory Record - Hamamatsu Photonics K.K. Pathology ✕

2 devices

1-2 of 2

PCCP authorized FDA software change control pathway

Regulatory consultant 510(k) submission support ecosystem

Hyman, Phelps & McNamara, P.C.

Regulatory activity signals

510(k) clearance pathway relevance detected

Medical device regulatory intelligence node

Consulting ecosystem involvement present

Data Source

Sourced from the FDA 510(k) public files . 174,883 total devices indexed.

Last updated: May 14, 2026