AcuityDRe— 510(k) K210919

Substantially Equivalent

Radmedix, LLC

FDA 510(k) clearance K210919 for AcuityDRe, Substantially Equivalent on 2021-04-30. Applicant: Radmedix, LLC.

Clearance details

Applicant: Radmedix, LLC
Product code: Code MQB
Advisory panel: Radiology
Date received: 2021-03-29
Decision date: 2021-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dayton, OH, US

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