K254143
- 510(k) number
- K254143
- Device name
- EM-TECH Passive Ultrasound Probe Strap
- Applicant
- EM-TECH Solutions, Inc. VA · US
- Product code
- ITX — Transducer, Ultrasonic, Diagnostic
- Decision date
- 2026-08-10
- Date received
- 2025-12-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain
Also available from FDA: K254143.pdf
Official FDA record: K254143
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.