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FDA 510(k) Applications Submitted by Polarean, Inc.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K231647
06/05/2023
XENOVIEW 3.0T Chest Coil
Polarean, Inc.
K212239
07/19/2021
XENOVIEW 3.0T Chest Coil
Polarean, Inc.
K223071
09/30/2022
Xenoview VDP
Polarean, Inc.
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