FDA 510(k)

UltraGuideCTR® image guided soft tissue release system

Número K: K252594 · 2025-09-29

Data da decisão2025-09-29

Código do produtoHRX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

UltraGuideCTR® image guided soft tissue release system is the device name listed in this FDA 510(k) record. The listed applicant is Sonex Health. It received FDA 510(k) clearance on 2025-09-29 under 510(k) number K252594. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the UltraGuideCTR® image guided soft tissue release system?

UltraGuideCTR® image guided soft tissue release system is a medical device that received FDA 510(k) clearance on 2025-09-29. The listed applicant is Sonex Health. The 510(k) number is K252594.

When did UltraGuideCTR® image guided soft tissue release system receive FDA 510(k) clearance?

UltraGuideCTR® image guided soft tissue release system received FDA 510(k) clearance on 2025-09-29, under 510(k) number K252594.

Who is the listed applicant for UltraGuideCTR® image guided soft tissue release system?

The FDA 510(k) record lists Sonex Health as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UltraGuideCTR® image guided soft tissue release system?

The FDA product code for UltraGuideCTR® image guided soft tissue release system is HRX.

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