# K180455: NeuralBot

- Pathway: 510(k) (Traditional)
- Applicant: Neural Analytics, Inc.
- Decided: May 22, 2018 after 91 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K974588 (1998). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122710: Transcranial Doppler with Robotic Probe Headband, Shenzhen Delicate Electronics Co., Ltd. (2013) Summary page 5.
- K160442: Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers, Neural Analytics, Inc. (2016) Summary page 5.

## Most influential descendants
- K213279: NovaGuide 2 Intelligent Ultrasound (2022), 0 descendants of its own

## Recalls of this device
- 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 NeuralBot when used with the Lucid M1 System is a medical ultrasound device which assists the user in the setup and acquisition of cerebral blood flow velocity via the patient’s temporal windows. It is intended for use as an adjunct to standard clinical practices for measuring and displaying cerebral blood flow velocity and the occurrence of transient emboli within the blood stream. The NeuralBot is intended to be used by healthcare professionals qualified by training in its safe and effective use. 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/K180455
Methodology: https://510kreport.com/methodology