510(k) K160442 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers
| Applicant | Neural Analytics, Inc., Los Angeles CA, US |
| Decision | Substantially Equivalent, Oct 21, 2016 |
| Received | Feb 17, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160442
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 1, 2023 | NovaSignal Corp. Lucid TCD 2.0 System, Model: NA-LUCM1. Transcranial Ultrasound System Open, Classified |
IYN | None listed |
| Feb 1, 2023 | NovaSignal Corp. NovaGuide Intelligent Ultrasound System, Model: NA-RBTSYS1. Comprised of NovaBot Automated Headset (AKA: NeuralBot, Model: NA-RBT1) and Lucid TCD 2.0 Transcranial Doppler Ultrasound (Model: NA-LUCM1) Open, Classified |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.