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510(k) K183685

O-Scan by Esaote, S.P.A. — Product Code LNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 2019
Date Received
December 28, 2018
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 Esaote, S.P.A.

  • K251901 — Magnifico Open (100009900) (March 5, 2026)
  • K253310 — 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30) (November 25, 2025)
  • K243253 — 6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70) (June 18, 2025)
  • K241671 — 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) (May 16, 2025)
  • K241133 — Magnifico Open (100009900); Magnifico MSK ( 100009910) (June 26, 2024)
  • K230179 — 6440 MyLabX90 (November 29, 2023)
  • K212419 — Magnifico Open, Magnifico MSK (February 4, 2022)
  • K212021 — 6430 MyLabX75, 6430 MyLab XPro75 (September 16, 2021)
  • K192157 — 6450 Ultrasound system (November 22, 2019)
  • K191072 — 7410 Ultrasound System (MyLabSigma) (June 10, 2019)

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)