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510(k) K243122

uMR Omega by Shanghai United Imaging Healthcare Co., Ltd. — Product Code LNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 2025
Date Received
September 30, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Nuclear Magnetic Resonance Imaging
Device Class
Class II
Regulation Number
892.1000
Review Panel
RA
Submission Type

Other clearances by Shanghai United Imaging Healthcare Co., Ltd.

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  • K252000 — uDR Arria & uDR Aris (November 26, 2025)
  • K252371 — uMR 680 (September 25, 2025)
  • K250045 — uWS-Angio Pro (September 24, 2025)
  • K251167 — uDR Aurora CX (September 19, 2025)
  • K250040 — uWS-Angio (September 12, 2025)
  • K250246 — uMR Jupiter (August 5, 2025)
  • K251839 — uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) (July 17, 2025)
  • K243547 — uMR Ultra (July 17, 2025)

Other clearances for product code LNH

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  • K253648 — Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/Q (February 23, 2026)
  • K260265 — MAGNETOM Flow.Ace; MAGNETOM Flow.Plus (February 23, 2026)
  • K253780 — SIGNA™ Bolt (February 6, 2026)
  • K253779 — SIGNA™ Sprint Select (February 5, 2026)
  • K253499 — Ascent3T Neonatal Magnetic Resonance Imaging System (January 26, 2026)
  • K252379 — AIR Recon DL (December 23, 2025)
  • K252838 — MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETO (December 19, 2025)