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510(k) K250443

MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile by Siemens Healthcare GmbH — Product Code LNH

K250443 is an FDA 510(k) premarket notification submitted by Siemens Healthcare GmbH for the device "MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile". The FDA issued a decision of Substantially Equivalent on June 16, 2025. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Siemens Healthcare GmbH has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 2025
Date Received
February 14, 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 Siemens Healthcare GmbH

  • K253264 — myAblation Guide (VC10A) (June 16, 2026)
  • K252548 — AI-Rad Companion Organs RT (April 10, 2026)
  • K253689 — syngo Dynamics (VA41F) (April 10, 2026)
  • K253057 — AI-Rad Companion Brain MR (January 22, 2026)
  • K252838 — MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETO (December 19, 2025)
  • K252608 — AI-Rad Companion Prostate MR (September 9, 2025)
  • K242551 — syngo Dynamics (Version VA41D) (April 3, 2025)
  • K242745 — AI-Rad Companion Organs RT (March 27, 2025)
  • K241770 — Prostate MR AI (VA10A) (March 5, 2025)
  • K240796 — myAblation Guide (VB80A) (August 6, 2024)

Other clearances for product code LNH

  • K260113 — uMR Astra (May 22, 2026)
  • 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)

FDA data resources