Home / 510(k) Clearances / K211118

510(k) K211118

SIGNA 7.0T by Ge Medical Systems, LLC — Product Code LNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 2021
Date Received
April 15, 2021
Clearance Type
Special
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)
  • K250379 — SIGNA Prime Elite (March 17, 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)

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)