NeuraSignal, Inc.
Los Angeles, CA, US
NeuraSignal, Inc. appears in FDA device records in Los Angeles, CA. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show 4 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to NeuraSignal, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Novasignal Corporation510(k), enforcement report, recall
510(k) clearance history
FDA records hold 1 510(k) clearance for NeuraSignal, Inc. in 2022.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2022 | 1 |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3013368530 | 3013368530 | NeuraSignal, Inc. | 1109 Westwood Blvd, Los Angeles, CA 90024 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2217-2024 | NovaGuide 2 Traditional Ultrasound , REF: NSC-TCDNG2 | Due to inadvertently disconnecting grounding cable of ultrasound system could result in electrical shock, electrical interference and/or equipment malfunction. | Class II | Open, Classified | |
| Z-2216-2024 | 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. | Class II | Open, Classified | |
| Z-1050-2023 | NovaGuide Intelligent Ultrasound System, Model: NA-RBTSYS1. Comprised of NovaBot Automated Headset (AKA: NeuralBot, Model: NA-RBT1) and Lucid TCD 2.0 Transcranial Doppler Ultrasound (Model: NA-LUCM1) | 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. | Class II | Open, Classified | |
| Z-1049-2023 | 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. | Class II | Open, Classified |
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Data as of , FDA export datePage updated Source: openFDA, public domain