ILUMIEN, Drageonfly OPTIS Imaging Catheter— 510(k) K150237

Substantially Equivalent

Lightlab Imaging, Inc.

FDA 510(k) clearance K150237 for ILUMIEN, Drageonfly OPTIS Imaging Catheter, Substantially Equivalent on 2015-05-05. Applicant: Lightlab Imaging, Inc..

Clearance details

Applicant: Lightlab Imaging, Inc.
Product code: Code NQQ
Advisory panel: Radiology
Date received: 2015-02-02
Decision date: 2015-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westford, MA, US

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