UltraSight Guidance— 510(k) K251416

Substantially Equivalent

Ultrasight , Ltd.

FDA 510(k) clearance K251416 for UltraSight Guidance, Substantially Equivalent on 2025-12-17. Applicant: Ultrasight , Ltd.. Device class: 2.

Clearance details

Applicant: Ultrasight , Ltd.
Product code: Code QJU
Device class: Class 2
Regulation: 21 CFR 892.2100
Advisory panel: Radiology
Date received: 2025-05-07
Decision date: 2025-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ness Ziona, IL

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.