ClearanceBrief
Company ยท JP

Hamamatsu Photonics K.K.

FDA 510(k) clearances and medical device recalls filed under this name, 1989 to 2026. Name variants (Inc, Corp, punctuation) are merged.

10510(k) clearances (2 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
PSYWhole Slide Imaging System4
MUDOximeter, Tissue Saturation2
IZISystem, X-Ray, Angiographic1
JAASystem, X-Ray, Fluoroscopic, Image-Intensified1
KPSSystem, Tomography, Computed, Emission1
OWNConfocal Optical Imaging1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Jul 22, 2026K260964NanoZoomer S540MD Slide Scanner System
Hamamatsu Photonics K.K., JP
PSY
Jul 15, 2026K253606NanoZoomer S20MD Slide scanner system; NanoZoomer S360MD Slide scanner system
Hamamatsu Photonics K.K., JP
PSY
Dec 22, 2023K233027NanoZoomer S360MD Slide scanner system
Hamamatsu Photonics K.K., JP
PSY
Sep 27, 2022K213883NanoZoomer S360MD Slide scanner system
Hamamatsu Photonics K.K., JP
PSY
Oct 25, 2016K162117NIRO-200NX DP
Hamamatsu Photonics K.K., JP
MUD
Jul 31, 2015K143219NIRO-200NX
Hamamatsu Photonics K.K., JP
MUD
Mar 27, 2014K133719PDE-NEO
Hamamatsu Photonics K.K.
IZI
Jan 13, 2012K110480PDE PHOTODYNAMIC EYE
Hamamatsu Photonics K.K.
OWN
Sep 17, 1998K982171HAMAMATSU PET SCANNER, MODEL SHR-22000
Hamamatsu Photonics K.K.
KPS
Dec 22, 1989K896331V2465P X-RAY IMAGE INTENSIFIER
Hamamatsu Photonics K.K.
JAA

Latest recalls

DateFirm and productCodeLinked 510(k)
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