Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers— 510(k) K160442
Substantially EquivalentNeural Analytics, Inc.
FDA 510(k) clearance K160442 for Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers, Substantially Equivalent on 2016-10-21. Applicant: Neural Analytics, Inc.. Device class: 2.
Clearance details
- Applicant
- Neural Analytics, Inc.
- Product code
- Code IYN
- Device class
- Class 2
- Regulation
- 21 CFR 892.1550
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Los Angeles, CA, US
Recent devices under product code IYN
view all- K261313 — Vivid Explorer/Vivid Advanced/Vivid Focus
- K254027 — Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90 CV/Marvo 90 Pro/Marvo 90 Exp/Marvo 90 Elite/Marvo Expert/Marvo 85/Marvo 85 Pro/Marvo 85 Exp/Marvo 85 Elite/Marvo Senior/Marvo 75 Elite/Marvo 75i/Fenix 95/Fenix 95 Elite/Fenix 90/Fenix 90 Elite/Fenix Expert/Fenix 85/Fenix 85 Elite/Fenix Senior/Fenix 75 Elite/Fenix 75i/Endo 80/Endo 90)
- K261668 — Venue Go
- K262311 — Alturion Series Diagnostic Ultrasound System
- K261288 — Handheld Ultrasound Scanner
More clearances from Neural Analytics, Inc.
view allAdverse events under product code IYN
product code IYN- Death
- 25
- Injury
- 163
- Malfunction
- 1,538
- Other
- 4
- Total
- 1,730
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K160442
K-number listed on FDA's recall record- Z-1049-2023 — Lucid TCD 2.0 System, Model: NA-LUCM1. Transcranial Ultrasound System
- Z-1050-2023 — 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)
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K160442.
Data sourced from openFDA. This site is unofficial and independent of the FDA.