510(k) Report

FDA applicant

Intelligent Ultrasound Limited

Cardiff, GB2 decisions2022–20230 recalls

FDA records 2 decisions for Intelligent Ultrasound Limited (Cardiff, GB) from 2022 to 2023: 1 510(k) clearance and 1 De Novo grant. All are in product code QRG (Ultrasound Guided Nerve Block Assist). Its devices cite 1 predicate, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, anesthesiology panel, where it files most

How often FDA has decided Intelligent Ultrasound Limited’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2022: 12023: 1
2022high 1 (2022) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Intelligent Ultrasound Limited by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • QRGUltrasound Guided Nerve Block Assist2decisions

Who builds on its devices?

Later devices cite its devices 2 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K232787ScanNav Anatomy Peripheral Nerve BlockIntelligent Ultrasound Limited · 20231cites it
  • DEN220024ScanNav Anatomy Peripheral Nerve BlockIntelligent Ultrasound Limited · 20221cites it

What has FDA decided for it lately?

  • K232787ScanNav Anatomy Peripheral Nerve BlockIntelligent Ultrasound Limited · 2023
  • DEN220024ScanNav Anatomy Peripheral Nerve BlockIntelligent Ultrasound Limited · 2022

All 2 as Intelligent Ultrasound Limited →

Other applicant names beginning “Intelligent”

FDA records each applicant name separately; these may or may not be the same firm.

Intelligent Hearing Systems 13Intelligent Implant Systems, LLC 6Intelligent Medical Devices, Inc. 4Intelligent Medicine, Inc. 4Intelligent Orthopaedics, Ltd. 3Intelligent Medical Systems 2Intelligent Surgical Lasers, Inc. 2Intelligent Product Limited Co. 2Intelligent Images Srl 2Intelligent Software Systems, Inc. 1Intelligent Sensory Concept SA 1Intelligent Medica Imaging, Inc. 1