FDA device listing

Siemens Magnetom Avanto Fit

FDA device listing 1581909090 · FUJITA CO., LTD.

Key facts

Proprietary names Siemens Magnetom Avanto Fit
Owner/operator FUJITA CO., LTD.
Owner/operator number 10092556
Premarket submissions K130885
Product codes LNH
Device names LNH - System, Nuclear Magnetic Resonance Imaging
Device class Class II
Classification regulations (21 CFR) 892.1000
Review panels Radiology
Registered establishments FUJITA CO., LTD.
Establishment registrations 3036666444
FEI numbers 3036666444
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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