Home / 510(k) Clearances / K221619

510(k) K221619

ECHELON Oval V6.2 MRI System by Fujifilm Healthcare Corporation — Product Code LNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 2023
Date Received
June 3, 2022
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 Fujifilm Healthcare Corporation

  • K241429 — ECHELON Synergy MRI System (August 13, 2024)
  • K240571 — OASIS MRI System (April 12, 2024)
  • K223426 — ECHELON Synergy MRI system (July 13, 2023)
  • K213829 — SCENARIA View (May 23, 2022)
  • K220295 — ARIETTA 50 (April 29, 2022)

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)