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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