FDA device listing

IQQA-BODYIMAGING

FDA device listing 1285270876 · EDDA TECHNOLOGY, INC.

Key facts

Proprietary names IQQA-BODYIMAGING
Owner/operator EDDA TECHNOLOGY, INC.
Owner/operator number 9066395
Premarket submissions K141745
Product codes LLZ
Device names LLZ - System, Image Processing, Radiological
Device class Class II
Classification regulations (21 CFR) 892.2050
Review panels Radiology
Registered establishments EDDA TECHNOLOGY, INC.
Establishment registrations 3004857110
FEI numbers 3004857110
Establishment operations Complaint File Establishment, Manufacturer
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

Browse all FDA device listings