ILUMIEN OPTIS System, OPTIS Integrated System, OPTIS Mobile System, with AptiVue Imaging Software version E.6— 510(k) K232386

Name: FDA 510(k) clearance K232386
Creator: U.S. Food and Drug Administration
Published: 2023-09-08

Substantially Equivalent

ABBOTT MEDICAL

FDA 510(k) clearance K232386 for ILUMIEN OPTIS System, OPTIS Integrated System, OPTIS Mobile System, with AptiVue Imaging Software version E.6, Substantially Equivalent on 2023-09-08. Applicant: ABBOTT MEDICAL. Device class: 2.

Clearance details

Applicant: ABBOTT MEDICAL
Product code: Code NQQ
Device class: Class 2
Regulation: 21 CFR 892.1560
Advisory panel: Radiology
Date received: 2023-08-09
Decision date: 2023-09-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Westford, MA, US

Download summary PDF View on FDA.gov ↗

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