FDA device listing

LM33-T

FDA device listing 1574715175 · Amirix Imaging LLC

Key facts

Proprietary names LM33-T
Owner/operator Amirix Imaging LLC
Owner/operator number 10091332
Product codes ITY
Device names ITY - Assembly, Tube Housing, X-Ray, Diagnostic
Device class Class I
Classification regulations (21 CFR) 892.1760
Review panels Radiology
Registered establishments AMIRIX IMAGING
Establishment registrations 3032799939
FEI numbers 3032799939
Establishment operations Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None listed 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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