Atlas FDA

RadiForce MX317W-PA

FDA 510(k) clearance K242545 · decided 2025-05-23

Clearance details

K-number
K242545
Device name
RadiForce MX317W-PA
Applicant
Eizo Corporation
Decision
Substantially Equivalent
Date received
2024-08-27
Decision date
2025-05-23
Days to decision
269 days
Clearance type
Abbreviated
Product code
PZZ
Device class
2
Regulation number
864.3700
Medical specialty
Pathology
Advisory committee
Pathology
Location
Hakusan, JP
Third-party review
No
Expedited review
No

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Devices cleared under the same product code - the starting set for predicate research.

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Recalls involving this device

No recalls on record reference this clearance.