ILUMIEN OPTIS System, OPTIS Integrated System, OPTIS Mobile System, with AptiVue Imaging Software version E.6
K-Number: K232386 · 2023-09-08
ApplicantABBOTT MEDICAL
Decision Date2023-09-08
Product CodeNQQ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
ILUMIEN OPTIS System, OPTIS Integrated System, OPTIS Mobile System, with AptiVue Imaging Software version E.6 is a medical device manufactured by ABBOTT MEDICAL. It received FDA 510(k) clearance on 2023-09-08 under approval number K232386. The device is classified under product code NQQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ILUMIEN OPTIS System, OPTIS Integrated System, OPTIS Mobile System, with AptiVue Imaging Software version E.6?
ILUMIEN OPTIS System, OPTIS Integrated System, OPTIS Mobile System, with AptiVue Imaging Software version E.6 is a medical device that received FDA 510(k) clearance on 2023-09-08. It is manufactured by ABBOTT MEDICAL. The 510(k) number is K232386.
When was ILUMIEN OPTIS System, OPTIS Integrated System, OPTIS Mobile System, with AptiVue Imaging Software version E.6 approved by the FDA?
ILUMIEN OPTIS System, OPTIS Integrated System, OPTIS Mobile System, with AptiVue Imaging Software version E.6 received FDA 510(k) clearance on 2023-09-08, under approval number K232386.
What company makes ILUMIEN OPTIS System, OPTIS Integrated System, OPTIS Mobile System, with AptiVue Imaging Software version E.6?
ILUMIEN OPTIS System, OPTIS Integrated System, OPTIS Mobile System, with AptiVue Imaging Software version E.6 is manufactured by ABBOTT MEDICAL.
What is the FDA product code for ILUMIEN OPTIS System, OPTIS Integrated System, OPTIS Mobile System, with AptiVue Imaging Software version E.6?
The FDA product code for ILUMIEN OPTIS System, OPTIS Integrated System, OPTIS Mobile System, with AptiVue Imaging Software version E.6 is NQQ.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.