510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K242545Substantially Equivalent

RadiForce MX317W-PA

Eizo Corporation, Hakusan, JP / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K242545 is the FDA 510(k) clearance record for RadiForce MX317W-PA, a class II device, cleared for Eizo Corporation on under FDA product code PZZ (Digital Pathology Display). FDA's definition for product code PZZ reads: "The digital pathology display device is intended for in vitro diagnostic use to display digital images of histopathology slides acquired from FDA-cleared whole-slide imaging scanners that are used for review and interpretation by trained...". FDA records list 23 510(k) clearances for Eizo Corporation, from to . As of , FDA records show no recalls naming K242545.

Clearance record

Decision date
Received
(269 days to decision)
Product code
PZZ Digital Pathology Display
Regulation
21 CFR 864.3700
Device class
Class II
Review panel
Pathology
Applicant
Eizo Corporation 153 Shimokashiwano, Hakusan, JP
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PZZ

Trailing 12 months

FDA records hold no clearances under product code PZZ in the trailing twelve months.

FDA records show no clearances under product code PZZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PZZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260