FDA 510(k), K182643, IRIS 1.0 System

FDA 510(k), K182643, IRIS 1.0 System

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510(K) Number: K182643
Device Name: IRIS 1.0 System
Manufacturer: Crystal Ong
Device Classification Name: System, Image Processing, Radiological
Regulation Number: LLZ
Classification Product Code: 09/24/2018
Date Received: 02/22/2019
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology

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