Clearance Summary
Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers received FDA 510(k) clearance under submission number K160442, sponsored by Neural Analytics, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2016-10-21.
- Submission: K160442
- Applicant / Sponsor: Neural Analytics, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1550
- Decision date: 2016-10-21
Classification & Regulation
This clearance is catalogued under FDA product code IYN and 21 CFR 892.1550, within the Radiology review panel as a Class II device.