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510(k) K192690

Upgrade Kit MR GUI PRO, MrJ 3300 Plus by Asg Superconductors S.P.A. — Product Code LNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 2019
Date Received
September 26, 2019
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 Asg Superconductors S.P.A.

  • K242258 — MROpen Evo (03-2000-00); MROpen Evo (03-4000-00) (November 26, 2024)
  • K193116 — MRopen EVO (December 20, 2019)
  • K190524 — MRopen 0.5 T (July 1, 2019)

Other clearances for product code LNH

  • K253862 — APERTO Lucent MRI System (April 6, 2026)
  • K253625 — Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing (March 27, 2026)
  • K260746 — S-scan Open (100001800) (March 27, 2026)
  • K251937 — nordicAudio (1.0) (March 20, 2026)
  • 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)