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510(k) K250379

SIGNA Prime Elite by Ge Medical Systems, LLC — Product Code LNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 2025
Date Received
February 11, 2025
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 Ge Medical Systems, LLC

  • K253780 — SIGNA™ Bolt (February 6, 2026)
  • K253779 — SIGNA™ Sprint Select (February 5, 2026)
  • K252379 — AIR Recon DL (December 23, 2025)
  • K251399 — SIGNA™ Sprint (September 11, 2025)
  • K250941 — Revolution Vibe (August 1, 2025)
  • K243667 — Sonic DL (June 5, 2025)
  • K241242 — SIGNA MAGNUS (October 17, 2024)
  • K233750 — ECG-less Cardiac (April 2, 2024)
  • K223491 — Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suit (May 25, 2023)
  • K230082 — Auto Segmentation (May 4, 2023)

Other clearances for product code LNH

  • K254277 — Embrace Neonatal MRI System (March 13, 2026)
  • K253413 — LiverMultiScan (v6.0) (March 9, 2026)
  • K251901 — Magnifico Open (100009900) (March 5, 2026)
  • 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)