FDA device listing

Neurophet AQUA AD Plus

FDA device listing 1458204798 · NEUROPHET, Inc.

Key facts

Proprietary names Neurophet AQUA AD Plus
Owner/operator NEUROPHET, Inc.
Owner/operator number 10086951
Premarket submissions K252496
Product codes LLZ, QIH
Device names LLZ - System, Image Processing, Radiological, QIH - Automated Radiological Image Processing Software
Device class Class II
Classification regulations (21 CFR) 892.2050
Review panels Radiology
Registered establishments NEUROPHET, INC.
Establishment registrations 3025602618
FEI numbers 3025602618
Establishment operations 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

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