NovaSignal Corp.

FDA Regulatory Profile

Summary

Total Recalls
4
510(k) Clearances
0
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2216-2024Class IINovaGuide 2 Intelligent Ultrasound, REFs: NSC-NVGSYS2 & NSC-NVGSYS2-CAMay 6, 2024
Z-2217-2024Class IINovaGuide 2 Traditional Ultrasound , REF: NSC-TCDNG2May 6, 2024
Z-1050-2023Class IINovaGuide Intelligent Ultrasound System, Model: NA-RBTSYS1. Comprised of NovaBot Automated Headset (December 16, 2022
Z-1049-2023Class IILucid TCD 2.0 System, Model: NA-LUCM1. Transcranial Ultrasound SystemDecember 16, 2022