K-number	K173478
Device name	OnSight 3D Extremity System
Applicant	Carestream Health, Inc.
Product code	JAK
Device class	Class II
Decision date	Jan 19, 2018
Decision	Substantially Equivalent
Regulation	892.1750

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Source

View the full FDA submission: accessdata.fda.gov

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OnSight 3D Extremity System

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