NovaSignal Corp.
FDA Regulatory Profile
NovaSignal Corp. has 4 FDA recalls, 1 inspection, 1 510(k) clearance and 0 compliance actions on record.
- Latest recall
- Z-2217-2024 · Class II · May 6, 2024
- Latest inspection
- Nov 1, 2017 · VAI
- Latest 510(k)
- Mar 2, 2022
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 4 | Oct 23, 2026 | Not stated | Current |
|---|
| 510(k) clearances | 1 | Oct 4, 2026 | Not stated | Current |
|---|
| Inspections | 1 | Oct 26, 2026 | Not stated | Current |
|---|
| Compliance actions | 0 | Oct 23, 2026 | Not stated | Current |
|---|
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2217-2024 | Class II | NovaGuide 2 Traditional Ultrasound , REF: NSC-TCDNG2 | May 6, 2024 |
| Z-2216-2024 | Class II | NovaGuide 2 Intelligent Ultrasound, REFs: NSC-NVGSYS2 & NSC-NVGSYS2-CA | May 6, 2024 |
| Z-1050-2023 | Class II | NovaGuide Intelligent Ultrasound System, Model: NA-RBTSYS1. Comprised of NovaBot Automated Headset… | Dec 16, 2022 |
| Z-1049-2023 | Class II | Lucid TCD 2.0 System, Model: NA-LUCM1. Transcranial Ultrasound System | Dec 16, 2022 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Nov 1, 2017 | Los Angeles, CA | Devices | Voluntary Action Indicated (VAI) | 3013368530 |
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K213279 | NovaGuide 2 Intelligent Ultrasound | Mar 2, 2022 |