Name: Predicase
Price: 199 USD

K-number	K232386
Device name	ILUMIEN OPTIS System, OPTIS Integrated System, OPTIS Mobile System, with AptiVue Imaging Software version E.6
Applicant	ABBOTT MEDICAL
Product code	NQQ
Device class	Class II
Decision date	Sep 8, 2023
Decision	Substantially Equivalent
Regulation	892.1560

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Source

View the full FDA submission: accessdata.fda.gov

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ILUMIEN OPTIS System, OPTIS Integrated System, OPTIS Mobile System, with AptiVue Imaging Software version E.6

Everything you need for a 510(k) submission. Nothing you don't.

ILUMIEN OPTIS System, OPTIS Integrated System, OPTIS Mobile System, with AptiVue Imaging Software version E.6