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
- Product 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- K261585 — Diagnostic Ultrasound System (Nuewa A20W) +10 more
- K261617 — Diagnostic Ultrasound System (11+ models)
- K263150 — V10 Diagnostic Ultrasound System +10 more
- K261933 — Voluson Expert 18; Voluson Expert 20; Voluson Expert 22
- K262548 — EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
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.