Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers— 510(k) K160442

Substantially Equivalent

Neural 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..

Clearance details

Applicant: Neural Analytics, Inc.
Product code: Code IYN
Advisory panel: Radiology
Date received: 2016-02-17
Decision date: 2016-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

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Adverse events under product code IYN

product code IYN

Death: 25
Injury: 163
Malfunction: 1,538
Other: 4
Total: 1,730

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.