510(k) Report

FDA applicant

Novasignal Corporation

Los Angeles, CA1 decision2022–20222 recalls

FDA records 1 decision for Novasignal Corporation (Los Angeles, CA) in 2022: 1 510(k) clearance. All are in product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic). Its devices cite 1 predicate, 0 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 Novasignal Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2022: 1
2022high 1 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

2in 2024

2024: 2
2022high 2 (2024) · low 0 (2022)2026

Class I Class II/III not classified

FIG. 1 — Novasignal Corporation 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?

  • IYNSystem, Imaging, Pulsed Doppler, Ultrasonic1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K213279NovaGuide 2 Intelligent UltrasoundNovasignal Corporation · 20222 recalls

The one decision as Novasignal Corporation →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K213279NovaGuide 2 Intelligent Ultrasound, REFs: NSC-NVGSYS2 & NSC-NVGSYS2-CAMay 6, 2024Class II
  • K213279NovaGuide 2 Traditional Ultrasound , REF: NSC-TCDNG2May 6, 2024Class II