510(k) Report

FDA applicant

Neural Analytics, Inc.

Los Angeles, CA2 decisions2016–20182 recalls

FDA records 2 decisions for Neural Analytics, Inc. (Los Angeles, CA) from 2016 to 2018: 2 510(k) clearances. All are in product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic). Its devices cite 3 predicates, 1 of them its own earlier devices. 2 recalls are linked to its devices.

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

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

How often FDA has decided Neural Analytics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2016: 12018: 1
2016high 1 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

2in 2022

2022: 2
2016high 2 (2022) · low 0 (2016)2026

Class I Class II/III not classified

FIG. 1 — Neural Analytics, Inc. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Neural Analytics, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • IYNSystem, Imaging, Pulsed Doppler, Ultrasonic2decisions

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

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.

  • K160442Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz TransducersNeural Analytics, Inc. · 20161cites it
  • K180455NeuralBotNeural Analytics, Inc. · 20181cites it

What has FDA decided for it lately?

  • K180455NeuralBotNeural Analytics, Inc. · 20181 recall
  • K160442Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz TransducersNeural Analytics, Inc. · 20162 recalls

All 2 as Neural Analytics, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K160442Lucid TCD 2.0 System, Model: NA-LUCM1. Transcranial Ultrasound SystemDec 16, 2022Class II
  • K160442NovaGuide Intelligent Ultrasound System, Model: NA-RBTSYS1. Comprised of NovaBot…Dec 16, 2022Class II