510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K260964Substantially Equivalent

NanoZoomer S540MD Slide Scanner System

Hamamatsu Photonics K.K., Hamamatsu City, JP / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K260964 is the FDA 510(k) clearance record for NanoZoomer S540MD Slide Scanner System, a class II device, cleared for Hamamatsu Photonics K.K. on under FDA product code PSY (Whole Slide Imaging System). FDA's definition for product code PSY reads: "The whole slide imaging system is an automated digital slide creation, viewing, and management system intended as an aid to the pathologist to review and interpret digital images of surgical pathology slides prepared from formalin-fixed...". FDA records list 10 510(k) clearances for Hamamatsu Photonics K.K., from to . As of , FDA records show no recalls naming K260964.

Clearance record

Decision date
Received
(121 days to decision)
Product code
PSY Whole Slide Imaging System
Regulation
21 CFR 864.3700
Device class
Class II
Review panel
Pathology
Applicant
Hamamatsu Photonics K.K. 812, Joko-Cho, Chuo-Ku, Hamamatsu City, JP
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PSY

Trailing 12 months
4 clearances under product code PSY in the twelve months to October 2026, July 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code PSY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20263
August 20261
September 20260
October 20260