K183320

Substantially Equivalent

Ilumien Optis, Optis Integrated, Optis Mobile

Applicant: St. Jude Medical (Now Abbott Medical)
Product code: NQQ
Advisory panel: Radiology
Date received: 2018-11-30
Decision date: 2019-04-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

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