Name: Predicase
Price: 199 USD

K-number	K252594
Device name	UltraGuideCTR® image guided soft tissue release system
Applicant	Sonex Health
Product code	HRX
Device class	Class II
Decision date	Sep 29, 2025
Decision	Substantially Equivalent
Regulation	888.1100

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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UltraGuideCTR® image guided soft tissue release system

Everything you need for a 510(k) submission. Nothing you don't.