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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

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

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  • K242745 — AI-Rad Companion Organs RT (March 27, 2025)
  • K241770 — Prostate MR AI (VA10A) (March 5, 2025)
  • K240796 — myAblation Guide (VB80A) (August 6, 2024)
  • K240294 — Syngo Carbon Enterprise Access (VA40A) (May 23, 2024)
  • K233753 — AI-Rad Companion (Pulmonary) (March 21, 2024)
  • K232744 — syngo Virtual Cockpit (VB10A) (December 21, 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)