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Novasignal Corporation

Last updated May 23, 2026

Information

Device	Model / Reference	Registries	Class	Status
Temporal Monitoring Headframe	NA-MOUNT2	FDA UDI	Class II	Active
Temporal Monitoring Headframe Foam Procedural Set, Packaged 10-Pack	NA-DSP3PK	FDA UDI	Class II	Active
Lucid Transcranial Doppler System	M1	FDA UDI	Class II	Unknown
NeuralBot	1.x	FDA UDI	Class II	Unknown
Remote Control Accessory	10-00002	FDA UDI	Class II	Active
2Mhz Monitoring Transducer - 8 foot	NA-PRB3	FDA UDI	Class II	Active
2-MHz Transducer, Handheld	40-00008	FDA UDI	Class II	Active
NovaGuide™ Intelligent Ultrasound System	05-00019	FDA UDI	Class II	Active
NovaGuide™ 2 Traditional Ultrasound System	NSC-TCDNG2	FDA UDI	Class II	Active
Temporal Monitoring Headset	40-00010	FDA UDI	Class II	Unknown
NeuralBot Procedural Set (Single Use)	1.x	FDA UDI	Class II	Unknown
NovaGuide™ 2 Intelligent Ultrasound System	05-00030	FDA UDI	Class II	Active
2-MHz Headset/Monitoring Transducer	40-00009	FDA UDI	Class II	Unknown
Lucid Transcranial Doppler Ultrasound System (Lucid TCD)	NA-LUCM1	FDA UDI	Class II	Active
NovaKit Exam Pack (NovaKit)	NA-DSP2	FDA UDI	Class II	Active
NovaKit™ 2 Exam Pack	25-00004	FDA UDI	Class II	Active
NovaBot Automated Headset	NA-RBT1	FDA UDI	Class II	Active
Monitoring Headframe Foam Procedural Set	NA-DSP3	FDA UDI	Class II	Unknown
NovaGuide 2 Intelligent Ultrasound	K213279	FDA 510(k)	Class II	Active

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Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
May 6, 2024	Z-2217-2024	—	open, classified	Due to inadvertently disconnecting grounding cable of ultrasound system could result in electrical shock, electrical interference and/or equipment malfunction.
May 6, 2024	Z-2216-2024	—	open, classified	Due to inadvertently disconnecting grounding cable of ultrasound system could result in electrical shock, electrical interference and/or equipment malfunction.
Dec 16, 2022	Z-1049-2023	—	open, classified	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 system will be rendered inoperable.
Dec 16, 2022	Z-1050-2023	—	open, classified	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 system will be rendered inoperable.