Clearance Summary
EM-TECH Passive Ultrasound Probe Strap received FDA 510(k) clearance under submission number K254143, sponsored by EM-TECH Solutions, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2026-08-10.
- Submission: K254143
- Applicant / Sponsor: EM-TECH Solutions, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1570
- Decision date: 2026-08-10
Classification & Regulation
This clearance is catalogued under FDA product code ITX and 21 CFR 892.1570, within the Radiology review panel as a Class II device.