FDA.report

510(k) K221136

Device
RadiForce MX243W
Applicant
EIZO Corporation
510(k) number
K221136
Product code
PGY  
Decision
Substantially Equivalent (SESE)
Decision date
2022-05-10
Date received
2022-04-19
Regulation
892.2050
Classification name
Display, Diagnostic Radiology
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Abbreviated
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Hiroaki Hashimoto
Address
153 Shimokashiwano Hakusan JP 924-8566 924-8566

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
04995047070542RadiForce®EIZO CORPORATION2025-09-12
04995047065661RadiForce®EIZO CORPORATION2025-07-11
04995047063957RadiForce®EIZO CORPORATION2022-06-03

Legacy Summary

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FDA Review

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