OnSight 3D Extremity System

System, X-ray, Tomography, Computed

Carestream Health, Inc.

The following data is part of a premarket notification filed by Carestream Health, Inc. with the FDA for Onsight 3d Extremity System.

Pre-market Notification Details

Device IDK173478
510k NumberK173478
Device Name:OnSight 3D Extremity System
ClassificationSystem, X-ray, Tomography, Computed
Applicant Carestream Health, Inc. 150 Verona Street Rochester,  NY  14608
ContactVictoria A. Wheeler
CorrespondentVictoria A. Wheeler
Carestream Health, Inc. 150 Verona Street Rochester,  NY  14608
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-11-13
Decision Date2018-01-19

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