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510(k) K190153

RadiForce MX216 by Eizo Corporation — Product Code PGY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 2019
Date Received
January 30, 2019
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Display, Diagnostic Radiology
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type

The device is intended for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners.

Other clearances by Eizo Corporation

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  • K231066 — CuratOR EX3242-FD (December 18, 2023)
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  • K223768 — RadiForce RX270 (April 20, 2023)
  • K221136 — RadiForce MX243W (May 10, 2022)
  • K211491 — RadiForce RX370 (July 12, 2021)

Other clearances for product code PGY

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