Chrysalis Intelligence · Sponsors · Novasignal Corporation

Novasignal Corporation

Los Angeles, CA, US · 1 510(k) clearances · 4 recalls

Total clearances
1
2022-03-02 → 2022-03-02
Last 12 months
0
Product codes
1
Most recent
2022-03-02
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
IYN System, Imaging, Pulsed Doppler, Ultrasonic Class II Radiology 1 2022-03-02
Safety

Recalls (4)

Class I (serious)
0
Risk of injury / death
Total recalls
4
Currently ongoing
4
Most recent
2024-05-06
DateSeverityStatusRecall # ProductCodeReason
2024-05-06 Class II Ongoing Z-2217-2024 NovaGuide 2 Traditional Ultrasound , REF: NSC-TCDNG2 Due to inadvertently disconnecting grounding cable of ultrasound system could result in electrical shock, electrical interference and/or equipment malfunction.
2024-05-06 Class II Ongoing Z-2216-2024 NovaGuide 2 Intelligent Ultrasound, REFs: NSC-NVGSYS2 & NSC-NVGSYS2-CA Due to inadvertently disconnecting grounding cable of ultrasound system could result in electrical shock, electrical interference and/or equipment malfunction.
2022-12-16 Class II Ongoing Z-1050-2023 NovaGuide Intelligent Ultrasound System, Model: NA-RBTSYS1. Comprised of NovaBot Automated Headset (AKA: NeuralBot, Mode… Transcranial Doppler/ultrasound system tablet has a faulty hard drive, which will cause the system to freeze and reboot. Initially, the system will reboot to a …
2022-12-16 Class II Ongoing Z-1049-2023 Lucid TCD 2.0 System, Model: NA-LUCM1. Transcranial Ultrasound System Transcranial Doppler/ultrasound system tablet has a faulty hard drive, which will cause the system to freeze and reboot. Initially, the system will reboot to a …
Filings

All 510(k) clearances (1)

Date K-number Device Code Class Specialty
2022-03-02 K213279 NovaGuide 2 Intelligent Ultrasound IYN Class II Radiology