FDA device listing

MAGNETOM AVANTO MR SYSTEM

FDA device listing 1571549835 · SIEMENS MEDICAL SOLUTIONS USA, INC.

Key facts

Proprietary names MAGNETOM AVANTO MR SYSTEM
Owner/operator SIEMENS MEDICAL SOLUTIONS USA, INC.
Owner/operator number 9002915
Premarket submissions K032428
Product codes LNH, LNI
Device names LNH - System, Nuclear Magnetic Resonance Imaging, LNI - System, Nuclear Magnetic Resonance Spectroscopic
Device class Class II
Classification regulations (21 CFR) 892.1000
Review panels Radiology
Registered establishments Siemens Healthcare Limited
Establishment registrations 3012127758
FEI numbers 3012127758
Establishment operations Foreign Exporter
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 1–9 UDI devices (GUDID) under the same submission
  • 1–9 Device listings citing the same submission
  • Yes Premarket submission listed

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device listings

Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.

Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database

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