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Lucid Transcranial Doppler Ultrasound System (Lucid TCD)

Novasignal Corp. · Model NA-LUCM1 · UDI-DI 00850681007221

ITXIYN Prescription
1
510(k) clearances
3,948
Adverse events (23 deaths)
147
Recalls
396
Facilities

Description

The Lucid TCD is a medical ultrasound system intended for use as an adjunct to the standard clinical practices for measuring and displaying cerebral blood flow velocity (CBFV) within the major conducting arteries and veins of the head and neck. Additionally, the Lucid TCD 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.

Recalls

DateFirmReason
2025-11-17Sheathing Technologies IncVaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may result in contamination during use, posing an infection risk.
2025-09-05Philips Ultrasound, IncTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-09-05Philips Ultrasound, IncTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-09-05Philips Ultrasound, IncTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-09-05Philips Ultrasound, IncTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-09-05Philips Ultrasound, IncTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-09-05Philips Ultrasound, IncTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-09-05Philips Ultrasound, IncTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-09-05Philips Ultrasound, IncTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-09-05Philips Ultrasound, IncTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.