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510(k) K260265

MAGNETOM Flow.Ace; MAGNETOM Flow.Plus by Siemens Shenzhen Magnetic Resonance , Ltd. — Product Code LNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 2026
Date Received
January 28, 2026
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 Siemens Shenzhen Magnetic Resonance , Ltd.

  • K251822 — MAGNETOM Free.Max; MAGNETOM Free.Star (November 20, 2025)
  • K250436 — MAGNETOM Flow.Ace; MAGNETOM Flow.Plus (June 16, 2025)

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)
  • 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)
  • K253489 — Swoop® Portable MR Imaging® System (December 12, 2025)