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Polarean, Inc.

FDA Regulatory Profile

Summary

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

Recent 510(k) Clearances

K-NumberDeviceDate
K243316XENOVIEW 3.0T Chest CoilNovember 19, 2024
K231647XENOVIEW 3.0T Chest CoilJune 29, 2023
K212239XENOVIEW 3.0T Chest CoilDecember 23, 2022
K223071Xenoview VDPDecember 23, 2022