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510(k) K243221

RadiForce RX570; RadiForce RX570-AR by Eizo Corporation — Product Code PGY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 2024
Date Received
October 7, 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

  • K252030 — RadiForce GX570; RadiForce GX570-AR (August 28, 2025)
  • K242545 — RadiForce MX317W-PA (May 23, 2025)
  • K241441 — RadiForce RX670; RadiForce RX670-AR (July 16, 2024)
  • 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)

Other clearances for product code PGY

  • K252780 — LCD Monitor (CL1902A, CL2103F) (December 19, 2025)
  • K253242 — LCD Monitor (C1216W, C822W, C821W) (October 29, 2025)
  • K252030 — RadiForce GX570; RadiForce GX570-AR (August 28, 2025)
  • K243031 — LCD Monitors C310S, G310S, C316S, G316S, C616W (October 25, 2024)
  • K242008 — Coronis OneLook (August 2, 2024)
  • K241105 — 3MP Color LCD Monitor (CL-S301) (August 1, 2024)
  • K241441 — RadiForce RX670; RadiForce RX670-AR (July 16, 2024)
  • K241499 — 21.3” 5MP Color LCD Display UMD5-21B01 (June 13, 2024)
  • K233336 — 21.3” 3MP Color LCD Display UMD3-21B01 (MD3-21B01) (May 21, 2024)
  • K240310 — LCD Monitors C310S, G310S, C316S, G316S, C616W (March 29, 2024)