FDA device listing

Doctors Review System

FDA device listing 2029011970 · Intelerad Medical Systems Incorporated

Key facts

Proprietary names Doctors Review System
Owner/operator Intelerad Medical Systems Incorporated
Owner/operator number 9040757
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 DIGISONICS, INC., Intelerad USA
Establishment registrations 1626313, 3022435840
FEI numbers 1626313, 3022435840
Establishment operations Complaint File Establishment, 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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