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FDA 510(k)

EM-TECH Passive Ultrasound Probe Strap

K-Number: K254143 · 2026-08-10

ApplicantEM-TECH Solutions, Inc.
Decision Date2026-08-10
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EM-TECH Passive Ultrasound Probe Strap is the device name listed in this FDA 510(k) record. The listed applicant is EM-TECH Solutions, Inc.. It received FDA 510(k) clearance on 2026-08-10 under 510(k) number K254143. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EM-TECH Passive Ultrasound Probe Strap?

EM-TECH Passive Ultrasound Probe Strap is a medical device that received FDA 510(k) clearance on 2026-08-10. The listed applicant is EM-TECH Solutions, Inc.. The 510(k) number is K254143.

When did EM-TECH Passive Ultrasound Probe Strap receive FDA 510(k) clearance?

EM-TECH Passive Ultrasound Probe Strap received FDA 510(k) clearance on 2026-08-10, under 510(k) number K254143.

Who is the listed applicant for EM-TECH Passive Ultrasound Probe Strap?

The FDA 510(k) record lists EM-TECH Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EM-TECH Passive Ultrasound Probe Strap?

The FDA product code for EM-TECH Passive Ultrasound Probe Strap is ITX.

Related Devices (Code: ITX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261170BA-004CCFujifilm CorporationK260161SmartGuide Disposable Guides and GridsUC-CARE , Ltd.K262474ND Needle Guidance SystemAccurate Access, LLCK261014Accuro® 3S Needle Guide KitRivanna Medical, Inc.K250883ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R)Olympus Medical Systems CorporationK250762ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R)Olympus Medical Systems Corporation

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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