Data / Medical devices / United States / NeuraSignal, Inc.

NeuraSignal, Inc.: FDA-registered device maker in Los Angeles, CA, United States, 2 510(k) clearances

Name: NeuraSignal, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

NeuraSignal, Inc. is registered with the FDA (registration 3013368530) in Los Angeles, CA, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 2, 2022. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3013368530
Address: 1109 Westwood Blvd, Los Angeles, CA, United States, 90024
Owner or operator: NeuraSignal, Inc. (10054619)
Roles: Manufacturer
First device listed: July 3, 2018
Registered through: 2026
Brand names listed: NeuralBot, NovaBot, NovaBot Automated Headset, NovaGuide, NovaGuide 2 Intelligent Ultrasound System, NovaGuide 2 Traditional, NovaGuide View

Devices it lists

Device	Product code	Class	Role	Source
Diagnostic Ultrasonic Transducer, Robotic	OQQ	2	Manufacturer	accessdata.fda.gov
System, Imaging, Pulsed Doppler, Ultrasonic	IYN	2	Manufacturer	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
March 2, 2022	K213279	NovaGuide 2 Intelligent Ultrasound	IYN	Substantially Equivalent	Novasignal Corporation	accessdata.fda.gov
May 22, 2018	K180455	NeuralBot	IYN	Substantially Equivalent	Neural Analytics, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
May 6, 2024	94673	Class II	Ongoing	NovaGuide 2 Intelligent Ultrasound, REFs: NSC-NVGSYS2 & NSC-NVGSYS2-CA	Due to inadvertently disconnecting grounding cable of ultrasound system could result in electrical shock, electrical interference and/or equipment malfunction.	accessdata.fda.gov
December 16, 2022	91467	Class II	Ongoing	Lucid TCD 2.0 System, Model: NA-LUCM1. Transcranial Ultrasound System	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.	accessdata.fda.gov

Compare with other makers

Updated June 27, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.