# K213279: NovaGuide 2 Intelligent Ultrasound

- Pathway: 510(k) (Traditional)
- Applicant: Novasignal Corporation
- Decided: Mar 2, 2022 after 152 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: 5 generations back to K974588 (1998). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180455: NeuralBot, Neural Analytics, Inc. (2018) Summary page 4.

## Recalls of this device
- May 6, 2024 · Class II · Z-2216-2024: Due to inadvertently disconnecting grounding cable of ultrasound system could result in electrical shock, electrical interference and/or equipment malfunction.
- May 6, 2024 · Class II · Z-2217-2024: Due to inadvertently disconnecting grounding cable of ultrasound system could result in electrical shock, electrical interference and/or equipment malfunction.

## Indications for use
NovaGuide 2 Intelligent Ultrasound is a medical ultrasound system 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 bloodstream. The system assists the user in the setup and acquisition of cerebral blood flow velocity via the patient's temporal windows. NovaGuide 2 Intelligent Ultrasound 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/K213279
Methodology: https://510kreport.com/methodology