Hamamatsu Photonics K.K. FDA Approvals

0 new drug approvals and 4 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
NanoZoomer S540MD Slide Scanner System510(k)Jul 22, 2026Pathology	Pathology	510(k)Substantially Equivalent (Abbreviated)	Jul 22, 2026
NanoZoomer S20MD Slide scanner system; NanoZoomer S360MD Slide scanner system510(k)Jul 15, 2026Pathology	Pathology	510(k)Substantially Equivalent (Abbreviated)	Jul 15, 2026
NanoZoomer S360MD Slide scanner system510(k)Dec 22, 2023Pathology	Pathology	510(k)Substantially Equivalent (Abbreviated)	Dec 22, 2023
NanoZoomer S360MD Slide scanner system510(k)Sep 27, 2022Pathology	Pathology	510(k)Substantially Equivalent (Traditional)	Sep 27, 2022