510(k) K212239— XENOVIEW 3.0T Chest Coil

Substantially Equivalent

Polarean, Inc.

Clearance details

Applicant: Polarean, Inc.
Product code: Code MOS
Advisory panel: Radiology
Date received: 2021-07-19
Decision date: 2022-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Research Triangle Park, NC, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.