EM-TECH Passive Ultrasound Probe Strap— 510(k) K254143
Substantially EquivalentEM-TECH Solutions, Inc.
FDA 510(k) clearance K254143 for EM-TECH Passive Ultrasound Probe Strap, Substantially Equivalent on 2026-08-10. Applicant: EM-TECH Solutions, Inc.. Device class: 2.
Summary
EM-TECH Solutions filed the EM-TECH Passive Ultrasound Probe Strap under product code ITX, diagnostic ultrasonic transducers. The record gives no model numbers.
Class II, 21 CFR 892.1570. Radiology is both the classification panel and the review panel. It came in as a Traditional 510(k).
EM-TECH filed from Chantilly, Virginia. Review took 231 calendar days (December 22, 2025 to August 10, 2026), ending in a substantially equivalent decision.
Clearance details
- Applicant
- EM-TECH Solutions, Inc.
- Product code
- Product code ITX
- Device class
- Class 2
- Regulation
- 21 CFR 892.1570
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chantilly, VA, US
Recent devices under product code ITX
view allAdverse events under product code ITX
product code ITX- Death
- 6
- Injury
- 137
- Malfunction
- 2,036
- Total
- 2,179
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.