K-number	DEN220077
Device name	ProSense System
Applicant	Icecure Medical
Product code	QXW
Device class	Class II
Decision date	Oct 3, 2025
Decision	Not Substantially Equivalent
Regulation	878.4355

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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ProSense System

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ProSense System