K250381
- 510(k) number
- K250381
- Device name
- Deepsight NeedleVue LC1 Ultrasound System
- Applicant
- DeepSight Technology, Inc. CA · US
- Product code
- IYO — System, Imaging, Pulsed Echo, Ultrasonic
- Decision date
- 2025-08-01
- Date received
- 2025-02-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K250381.pdf
Official FDA record: K250381
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.