Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers
FDA 510(k) clearance K160442 · decided 2016-10-21
Clearance details
- K-number
- K160442
- Device name
- Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers
- Applicant
- Neural Analytics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-02-17
- Decision date
- 2016-10-21
- Days to decision
- 247 days
- Clearance type
- Traditional
- Product code
- IYN
- Device class
- 2
- Regulation number
- 892.1550
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Los Angeles, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Lucid TCD 2.0 System, Model: NA-LUCM1. Transcranial Ultrasound System recall (Z-1049-2023) | NovaSignal Corp. | 2023-02-01 |
| NovaGuide Intelligent Ultrasound System, Model: NA-RBTSYS1. Comprised of NovaBot Automated recall (Z-1050-2023) | NovaSignal Corp. | 2023-02-01 |