FDA device listing

ImageShare

FDA device listing 1349136798 · Vigilant Medical Inc

Key facts

Proprietary names ImageShare
Owner/operator Vigilant Medical Inc
Owner/operator number 10042609
Product codes LMD
Device names LMD - System, Digital Image Communications, Radiological
Device class Class I
Classification regulations (21 CFR) 892.2020
Review panels Radiology
Registered establishments VIGILANT MEDICAL INC
Establishment registrations 3007950543
FEI numbers 3007950543
Establishment operations Repackager/Relabeler
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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