K250381 is an FDA 510(k) clearance for the Deepsight NeedleVue LC1 Ultrasound System. This device is classified as a System, Imaging, Pulsed Echo, Ultrasonic (Class II - Special Controls, product code IYO).
Submitted by DeepSight Technology, Inc. (Santa Clara, US). The FDA issued a Cleared decision on August 1, 2025, 171 days after receiving the submission on February 11, 2025.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1560.
| 510(k) Number | K250381 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 11, 2025 |
| Decision Date | August 01, 2025 |
| Days to Decision | 171 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IYO - System, Imaging, Pulsed Echo, Ultrasonic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1560 |