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FDA 510(k)

UltraGuideCTR® image guided soft tissue release system

K-Number: K252594 · 2025-09-29

ApplicantSonex Health
Decision Date2025-09-29
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Sonex Health. The 510(k) number is K252594.

When was UltraGuideCTR® image guided soft tissue release system approved by the FDA?

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

What company makes UltraGuideCTR® image guided soft tissue release system?

UltraGuideCTR® image guided soft tissue release system is manufactured by Sonex Health.

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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Related PubMed Literature

PMID: 42168293 Comparative in vitro and in vivo assessment of three experimental extracellular matrix meshes for soft tissue remodeling. Scientific reports (2026) PMID: 40942702 Digital Cardiovascular Twins, AI Agents, and Sensor Data: A Narrative Review from System Architecture to Proactive Heart Health. Sensors (Basel, Switzerland) (2025)

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Official Source

View on FDA Database →

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

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