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510(k) K222716

MX50N by Wide Corporation — Product Code PGY

K222716 is an FDA 510(k) premarket notification submitted by Wide Corporation for the device "MX50N". The FDA issued a decision of Substantially Equivalent on May 8, 2023. The device falls under product code PGY (Display, Diagnostic Radiology), a Class II device regulated under 21 CFR 892.2050. Wide Corporation has 19 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 2023
Date Received
Sep 8, 2022
Clearance Type
Traditional
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
510(k)

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

Other clearances by Wide Corporation

  • K222719 — CX50N (May 9, 2023)
  • K222717 — CL24N (Oct 31, 2022)
  • K222722 — CW60N (Oct 31, 2022)
  • K210493 — CX30N (CX30PQX) (Apr 14, 2021)
  • K210491 — CW120N (Apr 8, 2021)
  • K170781 — MX50N(MX50YQS) (Apr 4, 2017)
  • K170783 — CX50N(CX50YQS) (Mar 31, 2017)
  • K160354 — MX50T(MX50TQS) (May 2, 2016)
  • K160353 — MX50N(MX50YQS) (Apr 22, 2016)
  • K160348 — CX30N (CX30PQX) (Apr 14, 2016)

Other clearances for product code PGY

  • K262783 — RadiForce MX247W (Sep 1, 2026)
  • K261213 — Medical Monitor (40HT513D) (Jun 12, 2026)
  • K252780 — LCD Monitor (CL1902A, CL2103F) (Dec 19, 2025)
  • K253242 — LCD Monitor (C1216W, C822W, C821W) (Oct 29, 2025)
  • K252030 — RadiForce GX570; RadiForce GX570-AR (Aug 28, 2025)
  • K243221 — RadiForce RX570; RadiForce RX570-AR (Nov 27, 2024)
  • K243031 — LCD Monitors C310S, G310S, C316S, G316S, C616W (Oct 25, 2024)
  • K242008 — Coronis OneLook (Aug 2, 2024)
  • K241105 — 3MP Color LCD Monitor (CL-S301) (Aug 1, 2024)
  • K241441 — RadiForce RX670; RadiForce RX670-AR (Jul 16, 2024)

FDA data resources