ImaCor Inc.

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
4
Inspections
6
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0038-2026Class IIClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for uAugust 29, 2025
Z-0231-2025Class IIClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor ultrasound diagnSeptember 16, 2024

Recent 510(k) Clearances

K-NumberDeviceDate
K220490ImaCor Zura Handheld ZHH-010April 8, 2022
K142054IMACOR ZURA EVO IMAGING SYSTEMSeptember 29, 2014
K100989ZURA TEE SYSTEM WITH CLARITEE PROBEJune 25, 2010
K080223ZURA TEE SYSTEMJune 24, 2008