# K160442: Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers

- Pathway: 510(k) (Traditional)
- Applicant: Neural Analytics, Inc.
- Decided: Oct 21, 2016 after 247 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K002533 (2000). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002533: TCD 100M, PWD13 Transducer, Spencer Technologies (2000) Summary page 8.

## Most influential descendants
- K180455: NeuralBot (2018), 1 descendant of its own
- K213279: NovaGuide 2 Intelligent Ultrasound (2022), 0 descendants of its own

## Recalls of this device
- Dec 16, 2022 · Class II · Z-1049-2023: Transcranial Doppler/ultrasound system tablet has a faulty hard drive, which will cause the system to freeze and reboot. Initially, the system will reboot to a normal operable state but eventually the
- Dec 16, 2022 · Class II · Z-1050-2023: Transcranial Doppler/ultrasound system tablet has a faulty hard drive, which will cause the system to freeze and reboot. Initially, the system will reboot to a normal operable state but eventually the

## Indications for use
The Lucid M1 System is a medical ultrasound system intended for use as an adjunct to the standard clinical practices for measuring and displaying cerebral blood flow velocity within the major conducting arteries and veins of the head and neck. Additionally, The Lucid M1 System measures the occurrence of transient emboli signals within the blood stream. The device is not intended to replace other means of evaluating vital patient physiological processes, is not intended to be used in fetal applications, and is not intended to be used inside the sterile field.

Source page: https://510kreport.com/device/K160442
Methodology: https://510kreport.com/methodology