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FDA 510(k) Application Details - K241441
Device Classification Name
More FDA Info for this Device
510(K) Number
K241441
Device Name
RadiForce RX670; RadiForce RX670-AR
Applicant
EIZO Corporation
153 Shimokashiwano
Hakusan, Ishikawa 924-8566 JP
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Contact
Hiroaki Hashimoto
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PGY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/22/2024
Decision Date
07/16/2024
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
FDA Source Information for K241441
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