XENOVIEW 3.0T Chest Coil— 510(k) K231647

Substantially Equivalent

Polarean, Inc.

FDA 510(k) clearance K231647 for XENOVIEW 3.0T Chest Coil, Substantially Equivalent on 2023-06-29. Applicant: Polarean, Inc..

Clearance details

Applicant: Polarean, Inc.
Product code: Code MOS
Advisory panel: Radiology
Date received: 2023-06-05
Decision date: 2023-06-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Research Triangle Park, NC, US

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