Hamamatsu Photonics K.K. is one of 16283 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Hamamatsu Photonics K.K. - FDA 510(k) Cleared Devices
Recent clearances: NanoZoomer S540MD Slide Scanner System, NanoZoomer S20MD Slide scanner system, NanoZoomer S360MD Slide scanner system
10
Total
10
Cleared
0
Denied
Hamamatsu Photonics K.K. has 10 FDA 510(k) cleared medical devices. Based in Bridgewater, US.
Latest FDA clearance: Jul 2026. Active since 1989. Primary specialty: Pathology.
Browse the FDA 510(k) cleared devices submitted by Hamamatsu Photonics K.K. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Hyman, Phelps & McNamara, P.C. and Hyman, Phelps, & Mcnamara. 3 submissions have an FDA-authorized Predetermined Change Control Plan (PCCP), indicating AI or software-based device development.
FDA 510(k) Regulatory Record - Hamamatsu Photonics K.K.
10 devices
Cleared
Jul 22, 2026
NanoZoomer S540MD Slide Scanner System
Pathology
121d
Cleared
Jul 15, 2026
NanoZoomer S20MD Slide scanner system
Pathology
239d
Cleared
Dec 22, 2023
NanoZoomer S360MD Slide scanner system
Pathology
88d
Cleared
Sep 27, 2022
NanoZoomer S360MD Slide scanner system
Pathology
288d
Cleared
Oct 25, 2016
NIRO-200NX DP
Cardiovascular
88d
Cleared
Jul 31, 2015
NIRO-200NX
Cardiovascular
263d
Cleared
Mar 27, 2014
PDE-NEO
Radiology
112d
Cleared
Jan 13, 2012
PDE PHOTODYNAMIC EYE
General & Plastic Surgery
329d
Cleared
Sep 17, 1998
HAMAMATSU PET SCANNER, MODEL SHR-22000
Radiology
90d
Cleared
Dec 22, 1989
V2465P X-RAY IMAGE INTENSIFIER
Radiology
50d