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510(k) K241441

RadiForce RX670; RadiForce RX670-AR by Eizo Corporation — Product Code PGY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 16, 2024
Date Received
May 22, 2024
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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  • K233465 — RadiForce MX317W (December 21, 2023)
  • K231066 — CuratOR EX3242-FD (December 18, 2023)
  • K230684 — RadiForce MX217 (May 12, 2023)
  • K223768 — RadiForce RX270 (April 20, 2023)
  • K221136 — RadiForce MX243W (May 10, 2022)
  • K211491 — RadiForce RX370 (July 12, 2021)
  • K200485 — RadiForce RX1270, RadiForce RX1270-AR (March 23, 2020)

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